Title: Group Cognitive Behavioural Therapy for Insomnia (G-CBT-I) in Depression as a new model of therapy?
Background: Recently, researchers have suggested that insomnia and many psychological disorders are related and include bi-directional causation. A crucial indication is that insomnia is one of the diagnostic criteria for many psychological disorders including depression and the absence of a clear consensus as to how to conceptualise and define insomnia in depression may leave insomnia undertreated. The emerging view is that, for example, treating depression with Cognitive behavioural Therapy (CBT) can have important effects on the treatment outcome for depressive symptoms, however, insomnia symptoms persist if not treated separately. Further, insomnia may increase the risks of developing depression, while studies indicate that insomnia either caused or causing depression may become an independent disorder and possible treatment in isolation of depression may result in positive outcomes. Cognitive Behavioural therapy for Insomnia (CBT-I) has been proven to be a very effective treatment alone or in a CBT-I workgroup format (G-CBT-I). The main implication is that a better understanding of the management of sleep disturbances in depression could lead to a more effective CBT intervention or model that targets both co-existing disorders optimise therapeutic time and reduce the incidence of reoccurrence.
Aims: The present study aims to examine the effects of combined CBT and CBT-I treatments in patients with MDD when also insomnia is present.
Methods: 30 participants with insomnia and MDD will be recruited from Private and NHS services. Beck Depression Inventory (BDI) will be used to measure Depression severity, while the Pittsburgh Sleep Quality Index and the Insomnia Severity Index will be used to measure sleep quality. 15 clients of 30 will receive 6 CBT-I workgroup sessions along with their normal 6 CBT treatment for Depression.
Applications: The study will add to the literature on Insomnia and MDD. It will be useful for clinical psychologists, CBT therapists, GPs and other professionals working with insomnia and depressive clients. Findings will highlight the importance of enquiring about sleep quality in Depression and optimising therapeutic time. The need to develop interventions and models to target both improvements in psychological disorders sleep at the same time will be highlighted.
Existing literature has consistently demonstrated that disturbed sleep is a very common problem making it according to the Office of National Statistics data the most frequent of all primary mental health complaints (Singleton et al, 2001). In fact, with regard to UK prevalence of insomnia, 37% of the population in the UK is experiencing sleep difficulties affecting one in five men and one in three women, making it the world’s most common sleep disorder (Freeman et al., 2010; Morphy et al., 2007). Also, it is important to note, that the majority of people do not actually seek treatment for their sleep difficulties (Morin et al., 2006a; Bartlett et al., 2008).
Insomnia may cause impairments in a wide range of functions and has been linked with poor long-term quality of life and the consequences do not impact only the individual but they also contribute to a substantial burden on society such as impaired productivity, reduced daytime alertness, greater medical service utilisation, work absenteeism, and greater risk of traffic and work accidents (Edinger & Wohlgemuth, 1999; Dew et al, 2003). Specifically, according to the America Insomnia Survey (Roth, 2005), America loses 253 million days of productivity a year due to insomnia at a cost to the economy of $63 billion a year (Kleinman et. al., 2009; Chilcott et. al., 1996). Moreover, in terms of increased accident risk, studies show that work accidents are eight times more common in insomniacs than in the good sleepers (Morin & Espie, 2012).
There is also high comorbidity between insomnia and a range of psychological disorders, such as depression (Riemann & Voderholzer, 2003; Roane & Taylor, 2008), anxiety disorders (Taylor et al., 2003) and substance abuse (Ohayon et al., 1998), affecting 50% to 80% of those patients. For example, in bipolar disorder, during the manic phase 69% have inability to sleep and during the depression phase 99% of the patients being affected by inability to sleep, whereas, in schizophrenia, approximately 40% of the patients were found to meet the criteria for clinical insomnia (Krystal, A. D., 2006). Also, it affects generalized anxiety disorder and posttraumatic stress disorder and many other disorders (Germain et. al., 2005; Germain et. al., 2013).
Given that sleep disturbance has been identified as a diagnostic criterion for many disorders, until recently insomnia was perceived only as a cause of these psychological disorders which were characterized by difficulty in falling and staying asleep that resulted in daytime symptoms like fatigue and poor functioning (Seow et al, 2018). For instance, it was thought that if depression causes insomnia, treatment targeting depression could treat all of its comorbit symptoms as well as insomnia. However, many studies such as Manber et al., (2008) examined symptoms of insomnia in depressive patients and found that this is not the case. Their results proposed that when the aim of treatment is depression alone, there is a low possibility of effective management of insomnia, unlike, treatment aiming insomnia in depression seems to be more effective in reducing insomnia symptoms.
Furthermore, it has been shown that insomnia is actually a risk factor for causing them (Harvey, 2001). For instance, Buysse et al. (2008), presented interviews of 591 Swiss participants who were divided into insomnia groups versus those without insomnia. Participants with insomnia lasting more than two weeks were at greater risk for diagnosed as depressive at a later interview. This view is not surprising, considering insomnia is thought to be characterized by many of the symptoms of depression such as irritation, disturbances in sleep rhythms, disturbed attention, concentration and memory (Riemann et al. 2007). Hence, these results, consistent with numerous other studies (Paykel, 2007; Franzen & Buysse, 2008;) proposed that insomnia can be left over after depression remission but also that treatment of insomnia in depressive patients is possible and significantly treatable when treated independently.
Consequently, DSM-5 is now recognising insomnia disorder as a condition requiring independent clinical attention regardless of other medical problems that may be present and research recommends Cognitive Behavioural Therapy for Insomnia (CBT-I) as the one of the most effective evidence based therapeutic options and that should be the first line therapy offered to clients (Riemann et al., 2017). This has implications for treatment because it indicates that insomnia should be conceptualised and targeted in treatment plan alone, even if there are other disorders present.
Yet still, the general idea that if the primary disorder (e.g depression) is targeted in treatment, the secondary disorder (e.g insomnia) will remit, it is still assumed. Despite insomnia’s high prevalence, negative impact on individual and society, direct and indirect costs and DSM-5 recommendations indicating to consider insomnia to be an independent clinical disorder regardless its causality, research consistently show that insomnia remains an under-recognized, under-diagnosed, and under-treated condition. The main implication seems to be that clinical therapists’ report a lack of knowledge and training in assessment, treatment of insomnia and sleep interventions, and as a result, they manage insomnia mainly through basic sleep hygiene recommendations and/or hypnotic medication usually by general practitioners (Qaseem et al., 2016).
Insomnia and Depression
In terms of depression, symptoms include thoughts of worthlessness, hopelessness and feelings of guilt. Moreover, depressed patients may exhibit cognitive and physical manifestations such as disturbed attention and memory, weight loss, thoughts of self harm and suicide, fatigue and most often insomnia symptoms (Gleitman et al., 2004). Symptoms in depression may vary among clients but it seems that insomnia is the most persistent physical symptom. Depression is by far the most studied in terms of sleep disturbance with more than 90% of individuals with depression having clinical insomnia (Seow, 2016, Thase 1999).
Research shows that it is not clear if insomnia in depression follows a cause and effect model, because sometimes depression causes insomnia symptoms and other times the reverse is true (Stepanski & Rybarczyk, 2006). In insomnia, restlessness, racing mind and the constant effortless attempts to sleep provoke a greater tendency to depression, whereas in depression people have highly disrupted sleep (Pigeon et al., 2008)
With regards to results from the studies someone could indicate that for those suffering from insomnia and depression, treating insomnia independently can also alleviate symptoms of depression. Interestingly, Morawetz, (2003) tested this hypothesis in 86 depressive patients suffering from insomnia. The sample was assigned in two groups, one using an eight weeks period of self help program to improve their quality of sleep and the other group receiving CBT for depression and taking usual antidepressant treatment. Results showed that 70% of the group which learnt to sleep better, surprisingly, were found no longer depressed. It seems that improvement in sleep habits involves in depression treatment. Strong evidence of this view comes after the second finding of the study and the results of the second group. The second group using only antidepressants, after eight weeks, found to have no signs of improvement neither for depressive symptoms nor for insomnia.
Furthermore, according to Seow et. al., (2018) there is a lack of diagnosis and treatment of insomnia in many clinical populations including depression. Using 400 participants with major depressive disorder, bipolar disorder, anxiety disorders, schizophrenia found that 50% of all of them and 45% of the patients with major depressive disorder had seek treatment of insomnia from a health professional but only 12% of them were given some form of sleep hygiene recommendations. In line with many other studies, these findings highlight the absence of a clear consensus as to how to conceptualise and define insomnia in depression and that may leave insomnia undertreated.
CBT-I as treatment of insomnia
According to the European Sleep Research Society and the American Academy of Sleep CBTi is accepted as the best treatment offered to insomnia (Riemann et. al., 2017; Qaseem et al., 2016). CBT-I it is usually delivered over six weekly sessions and uses techniques that strengthen the bed-sleep connection such as stimulus control therapy, realign the homeostatic mechanisms and the circadian rhythm by sleep restriction therapy and decrease anxiety and cognitive distortions about sleep by psycho-education about sleep, sleep hygiene, cognitive construction and relaxation training (Espie et al., 2001).
Psycho education about sleep
Psychoeducation typically is around the importance of light and darkness and our internal clock as well as around ‘sleep hygiene’ and lifestyle behaviours such as caffeine, alcohol and exercise are reviewed. Also, other unhelpful bedtime behaviours such as clock monitoring and sleep/wake cycles are explained.
During treatment clients are asked to complete each week a sleep diary to determine their average bedtime, rising time, sleep onset and offset time, total sleep time and total time in bed.
Progressive muscle relaxation and breathing techniques targeting the ‘racing mind’ are also described for participants to practice in the day and then use the techniques during bedtime or when is difficult to fall asleep.
Using the sleep diaries as part of the stimulus control techniques to become aware of when being awake and when being asleep, participants are strengthening their sleep-bed association in order to make their bed a stronger cue for sleep.
Sleep restriction is a technique which paradoxically is asking people with sleep difficulties to spend less time sleeping. These techniques has been proven very effective and by using simple sleep time calculations it teaches how to strengthen our sleep system and weaken our wake system so that we fall asleep and stay asleep at night more easily.
Cognitive restructuring is carried out to identify client unhelpful thinking and anxiety around sleep so that with the help of the therapists could change these into alternative helpful ones.
Aims and Hypotheses
Recently, it is been emphasized that CBT-I is effective, but it has also considered as a time-consuming and cost-inefficient treatment, especially when differential diagnosis is present such as in cases of depression and insomnia. On the other hand, group work is an effective and efficient way of addressing the increasing demand and client severity and a cost-effective alternative to individual CBT-I therapy for the management of insomnia (American Group Psychotherapy Association (AGPA), 2011).
CBT in groups, depending on how are led, can be structured as therapeutic groups, theme groups or psycho-educational (Butler et. al., 2006). Psycho-educational groups are designed to allow members to learn and practice new skills by teaching concepts, skills, and practices in a safe environment which seems to be in highly demand for people with sleep difficulties. Group Cognitive Behavioral Therapy for Insomnia (G-CBT-I), although has been used universally and there is a weight of evidence for its efficacy and both CBT-I and G-CBT-I are popular and evidence based approaches, whether are equally efficacious or if they may contribute in combination for the treatment in differential diagnosis is not clear.
The main implication is that treatment should target both co-existing conditions separately, while studies indicate that insomnia either caused by or causing depression become an independent disorder and possible treatment in isolation of depression medication may result in positive outcomes (Paykel, 2007; Franzen & Buysse, 2008; Manber et al. 2008). Therefore, there is a need for considering this bidirectional relationship, while, effective management of sleep disturbances in depression may reduce an important factor in depressive relapse and recurrence.
Hence, the current study, to our knowledge, will be the first to explore and report that G-CBT-I may be an effective addition in targeting insomnia in depression treatment which may optimise therapeutic time and cost.
- To add to the literature on insomnia and depression.
- To examine the relationship between insomnia and depression in adults.
- To examine the importance of enquiring about sleep quality in depression and other psychological disorders.
- To examine the efficacy of individual and group formats of CBT-I in depression.
- To examine the efficacy of G-CBT-I as an addition in targeting insomnia in depression treatment.
- Participants with Depression and Insomnia who participated in G-CBT-I (Group B) will have lower depression mean post treatment HADS scores than the depression mean post treatment HADS scores of participants who participated in CBT for depression alone (Group A).
- Participants with Depression and Insomnia who participated in G-CBT-I (Group B) will have lower insomnia mean post treatment PSQI scores than the insomnia mean post treatment PSQI scores of participants who participated in CBT for depression alone (Group A).
Plan of Investigation
20 participants between the ages of 18-50 with insomnia and depressive symptoms wanting to start CBT therapy will be recruited be through newspaper advertisement, universities forums and boards, community and cafes postings, and brochures in private practices. The advertisements will invite participation in a study on depression and insomnia and will not disclose the study hypothesis. The advertising materials will state that “participants will receive CBT for depression.” Recruitment will take place between January 2019 and March 2018 and the study protocol will be approved by the human subjects and ethics committee at University of Glasgow. We will consider choosing our sample carefully in order to represent the larger population but also in terms of their age, gender, social and economical status we will randomly allocate them into groups. All participants will provide a written consent for participation.
Inclusion criteria for participation:1) Be between the ages of 18 and 75. 2) Meet the DSM-5 criteria for depression determined by a score at least 12 on the 17-item Hamilton Rating Scale for Depression. 3) Meet DSM-5 criteria for insomnia based on the PSQI; a) Difficulty initiating sleep or difficulty maintaining sleep or early morning awakening, or non-restorative sleep, b) at least 3 nights per week in addition to c) daytime distress or impairment with d) a total sleep time ≤ 6.5 h per night, 4) Be free of any medication for depression or insomnia for at least 14 days prior to the assessment visit.
Exclusion criteria for participation:1) suicidal potential or risk by a score ≤ 4 reflected from CORE 34, 2) drug or alcohol abuse, 3) experiencing psychotic features, 4) history of seizure disorder, 5) presence of diseases, 6) intellectual or physical disabilities, 7) current ongoing psychotherapy, medication for insomnia or depression, alternative therapy, or any other treatment of claimed efficacy for depression or insomnia 8) apneas, 9) periodic limb movement, 10) parasomnia, 11) narcolepsy, or 12) other than insomnia sleep disorder, 13) comorbid psychiatric conditions other than depression. These inclusion/exclusion criteria being applied will help increase the homogeneity of the group under examination, therefore increasing the power of the study.
Validity in a quantitative study is the extent to which the tests or assessment tools of our study are measuring the concept we want to explore accurately. It is very important the tools we are using to be valid in order for the results to be accurately applied and interpreted. For example, in my study I want to assess depression and insomnia and if the tools I was using were measuring anxiety would not be valid. Reliability in a research can be internal or external. Internal is the consistency of a measure when is actually measuring what we want it to measure. External reliability means that what our tools are measuring can be generalized beyond what we are using them for. For example, a sleep or a depression questionnaire should be able to detect sleep and depression in all my participants regardless their age, gender or social or economical status.
Demographic information including age, gender, education, marital status, employment and ethnicity will be collected.
Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE–OM)
CORE-OM (Evans et. al., 2000) is a 34 item self-report instrument with four components measuring well-being, symptoms, function and risk. The CORE–OM is a reliable and valid questionnaire with (Cronbach’s alpha = .80) and good sensitivity to change, making it suitable for pre and post treatment score differences. It is a standardised outcome measure widely used for its effectiveness from primary and secondary care settings as well as private psychological services offering therapy (Connell et. al., 2007). In my study, I will use CORE-OM to get a mean score of the current psychological global distress of each participant. This will allow profiling the client, their presenting problems, suitability of CBT and potential risk.
Pittsburgh Sleep Quality Index (PSQI)
Using and implement valid and reliable tools and methods in our research studies is very important and in my quantitative study I will use the Pittsburgh Sleep Quality Index (PSQI) (Buysse, et al., 1989), to assess sleep quality and the Hamilton Depression Rating Scale (HAM-D) to assess depression.
PSQI is a nineteen item self-report questionnaire which consists seven component scores assessing; subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication used for sleep, and daytime dysfunction due to sleepiness. A total score of the seven components will be used to assess overall sleep quality with scores rating from 0 to 21. PSQI validation has been used in many studies with mixed-age healthy controls, individuals with major depression, insomnia and other conditions and has be found to be a valid and reliable tool with internally consistency (Cronbach’s alpha = .83) for the detection of significant sleep disturbance (using a threshold score of 6). This will allow distinguishing between primary or secondary causes of insomnia.
Hamilton Depression Rating Scale (HAM-D)
Similarly, the HAM-D (Hamilton, 1960) consist 21 questions reflecting 21 symptoms and attitudes of depression that are each rated in intensity. HAM-D has been extensively used to evaluate depression in various clinical settings at all levels of health care services but has also been used to assess depression in general population samples and has been found to be a valid and a reliable tool with internal consistency (Cronbach’s alpha = 0.8).
Therefore, using valid and reliable assessment tools will increase my study’s validity and reliability in terms of data collection and interpretation of results and at the same time will allow my results to be generalised to the population.
Two response variables HAM-D and PSQI scores at two time points will be measured for two groups: an intervention group, who will receive 6 CBT sessions for depression along with 6 G-CBT-I sessions, and a control group who will receive 12 individual sessions of CBT for depression. Both groups will be measured before and after the interventions.
My research question will be whether the mean change in the treatment outcomes from pre to post differs in the two groups. This is a repeated measures experiment with one between subjects factor (intervention group) and one within-subjects factor (time) and this is directly measured by the time*group interaction in the repeated measures ANOVA.
The dependent variable is the type of intervention; whether participants received the 6 sessions of CBT for Depression along with 6 sessions of G-CBT-I or 12 sessions of CBT for Depression. The independent variables are their HAM-D and PSQI scores after receiving the interventions.
But even within each group, there is going to be a lot of variation in participants’ HAM-D scores because of the interventions they have received. In order to control this variation, I will then use pre test HAM-D scores as a covariate, so I can control for where participants started out. With this way, I will get a clearer picture of whether participants improved in depression due to the G-CBT-I or due to the CBT sessions for depression they received.
The ANCOVA answers whether the post-test means, adjusted for pre-test scores, differ between the two groups. It answers specifically if one group has a higher mean after the intervention.
The adjustment for the pre-test score in ANCOVA has two benefits. One is to make sure that any post-test differences truly result from the intervention, and aren’t some left-over effect of pre-test differences between the groups.
The other is to account for variation around the post-test means that comes from the variation in where the participants started at pre test. So when the research question is about the difference in means at post-test, this is a great option. It’s very common in medical studies because the focus there is about the size of the effect of the intervention. Using both ANOVA and ANCOVA will increase the reliability and validity of my study.
Participants who express initial interest in the study will be assessed as follows:
1) a 15 minutes telephone screening interview to ensure basic study criteria were met
2) 30 minutes in person interviews and participants will be asked to complete the CORE-OM, HAM-D and the PSQI.
Following recruitment, participants will be randomized to one group of people with depression and insomnia who will receive 6 sessions of CBT for depression and participate in a 6 session G-CBT-I (N = 15) and to other group of people with depression and insomnia who will receive 12 CBT sessions for depression (N = 15) only. Randomization will be performed in blocks of 2 and separate randomization tables will be created for individuals with HAM-D scores above and below baseline characteristics in respect to depression and insomnia to ensure equal distribution of depression severity in the two groups. Demographic characteristics will be also randomised between the two groups.
CBT treatment of depression
In current study , CBT treatment for depression for all participants will follow the adapted CBT manual transcript which many other research studies used recommended by the National Institute for Mental Health (NIMH) and the Institutional Funds for Research and it has been showed to be effective in treating depression (Hagen & Gråwe, (2006). Following screening and assessment (HAM-D, PSQI), However, the core elements of CBT for depression, such as psycho-education, behavioral activation, and cognitive restructuring, were central to all treatments. psycho-education around depression, the CBT model of depression and vicious cycles will be implemented, to introduce participant to the therapy in which they are going to participate. Therefore, intervention will focus on learning how thoughts and actions influence our feelings and therapist will collaboratively work with the participant on breaking the low activity cycles; behaviour, the negative thoughts cycles; cognitive restructuring, how other people affect our mood. The last sessions will focus on progressively delegate the participant for the end of the individual therapy, lapse and relapse and emphasise the importance of practicing the learning and coping strategies. General CBT sessions format will also be followed such as agendas and homework assignments.
Four trainee CBT therapists as part of their course placement will assess and deliver CBT for depression following the CBT manual for depression. One CBT-I experienced qualified CBT therapist will deliver the 6 G-CBT-I sessions to Group B along with one trainee CBT therapist who will co –facilitate G-CBT-I sessions.
Data will be analysed using the Statistical Package for Social Sciences (SPSS) computer package. Descriptive statistics will be used to examine demographic data, depression and sleep quality data. Assuming data will be relatively normally distributed, further analyses will be used and in order to maintain a significance level of 0.05, corrections will be made for multiple comparisons.
As the PSQI is a continuous measure, which views sleep disturbance, and it is not diagnostic in nature, further analyses will therefore examine relationships between subjective sleep (PSQI) and depression symptoms (HAM-D).
It is hypothesised that participants with Depression and Insomnia who participated in G-CBT-I (Group B) will have lower depression mean post treatment HADS scores than the depression mean post treatment HADS scores of participants who participated in CBT for depression alone (Group A). Also, that participants with Depression and Insomnia who participated in G-CBT-I (Group B) will have lower insomnia mean post treatment PSQI scores than the insomnia mean post treatment PSQI scores of participants who participated in CBT for depression alone (Group A).
Independent t-tests will examine the differences in treatment outcome between those who received 6 session of G-CBT-I and those who did not.
Health and Safety Issues
Informed consent will be sought prior to participants. All one to one CBT and G-CBT-I sessions will be carried out in a safe in a safe environment (The Centre of Therapy), where trained staff members will always be present.
Risk procedures will be issued and informed to participants before sessions. All participants will be informed that if at any points the researchers or therapists feel that there is a risk to self or to others will need to invite someone else in the confidentiality agreement. Trainee therapists will help and explore risk with each participant during assessment (CORE-OM, HAM-D, and PSQI), to make sure no plans of suicide or harming others and safety plans are in place. Supports and available help will be discussed with each participant during the assessment.
Participants will be also informed that they are free to withdrawal the study at any point for any reason. Their data will be kept confidential and will not be shared with anyone else apart from the trainee therapists, supervisors and researchers running the study.
Supervision will be available from Professor Biello a clinical psychologist specialised in insomnia and other trained supervisors from The Centre of Therapy. Supervision for all therapists will take place once a month.
Participant will have expressed an interest in CBT and will want to receive CBT treatment. Suitability for CBT will be explored during assessment period.
Participants will provide informed consent to take part in the study. They will be made aware that their data will remain anonymous and strictly confidential and they will be free to withdraw from the study at any time, without giving a reason. All information obtained throughout the duration of the study will be saved on a password-protected computer, or in a locked filing cabinet, to which only the researchers, supervisors and therapists will have access. Groups will receive 12 or 6, fifty minutes sessions of individual CBT for depression with up to a further six sessions which will be covered from the additional costs, if judged to be clinically appropriate by the trainee therapist. Ethical approval will be sought from the local ethics committees in Greater Glasgow.
Costs will include photocopying, stationary and postage. Costs associated with the room renting, therapy and supervision costs are estimated to £2,500.
12 x £10 room renting for CBT sessions received from Group A = £1,200
6 x £10 room renting for CBT sessions received from Group B = £600
6 x £100 G-CBT-I sessions received from Group B = £600
Supervision costs: £700
Other Costs =£600
Total Cost estimated: £2,500
The current research will add to the existing literature on Insomnia and depression. It will be useful for clinical psychologists, CBT therapists, GPs and other professionals working with insomnia and depressive clients. Findings will increase awareness and highlight the importance of enquiring about sleep quality in Depression.
Increased awareness may lead to the development of interventions and models to target both insomnia and improvements in depression and other psychological disorders.
Greater knowledge in CBT-I and G-CBT-I may lead to more effective treatments which may optimise therapeutic time and cost.
The present research may lead to further exploration of treating insomnia independently can also alleviate symptoms of depression. Additional research examining the risk to depression relapse or other disorders if insomnia remains untreated for a long time could minimise the incidence of reoccurrence.
This study will be limited to the extent that participants will only be classified in accordance to PSQI scores in terms of their sleep disturbance and in accordance to HAM-D for their depression. They will not be supplied with an actiwatch or a sleep diary or receive a depression diagnosis as in other sleep studies.
Also, although, in the current study G-CBT-I will target only insomnia, participants may be benefited from therapeutic factors such as imparting information which might include both didactic and direct advice and other therapeutic factors which open the pathway to therapeutic change towards depression. This may have an impact on the results in terms of the comparison between the groups’ depression improvement scores. Nevertheless, at the same time it will highlight the therapeutic effectiveness of G-CBT-I in people suffering from both depression and Insomnia.
Moreover, although that basic CBT methods and therapeutic interviewing will be all delivered from trainee therapists increases the homogeneity of the treatment outcome, regardless the level of improvement, it would be best for therapy to be delivered by qualified and experienced CBT therapists instead of trainee therapists, as this may have implications in the treatment outcome or rapport building.
It may have been more appropriate in another study to consider using actiwatches and sleep diaries as the main measurement of insomnia in order to provide a more complete assessment of sleep. This may lead to a more valid assessment of depression and insomnia and as no discrepancies between sleep diary and sleep questionnaires will be examined.
With regards to studies that show that if insomnia is not targeted during therapy for depression, relapse of depression is high, future studies could explore the incidence of reoccurrence by adding a continuation in the current study, for example, assess participants in the future, and compare assessment results after 3 or 6 months and compare results.
Statistical analysis Data were analyzed using Stat View-J5.0 for Windows (SAS Institute, Tokyo, Japan). Each parameter for demographic data was compared between the two groups, I-CBT-I and G-CBT-I, using the unpaired t-test or c2 test. Analysis of variance (ANOVA) with repeated measures was used to determine variances over time (pretreatment and post-treatment), between the two groups (I-CBT-I and G-CBT-I), along with the interaction of the group over time. P-values of group difference were calculated using pre-treatment da ata. Statistical significance was determined at P < 0.05.
Participants received 12 weeks of EsCIT, open label and concomitantly 7 individual sessions of CBTI or CTRL therapy. The frequency of CBTI and CTRL treatment was identical (5 weekly sessions followed by 2 biweekly sessions). EsCIT was selected as a representative of the most commonly prescribed class of antidepressant medications, the selective serotonin inhibitors (SSRIs). It has the added advantage that the proportion of patients reporting daytime somnolence (6%) and insomnia (9%) as side effects is equivalent (product insert: http://www. frx.com/products/lexapro.aspx). The initial dose of EsCIT was 5 mg. It was increased to 10 mg during the second week, with additional increases up to 20 mg based on clinical response and tolerability. Medication management followed a standardized protocol33 and included biweekly visits for the first 2 months and a final study visit at the end of treatment (end of week 12).
CBTI included the following components: (a) education about normal sleep, sleep in depression, circadian rhythms, and impact of substances (Session 1); (b) sleep restriction34 and stimulus control instructions35 (introduced during Session 2 and adjusted during subsequent sessions); (c) management of stress and of cognitive and somatic arousals (Session 3); (d) cognitive restructuring36 (provided throughout the intervention); and (e) instructions for continued schedule adjustment and relapse prevention (Session 7).
The CTRL intervention consisted of a quasi-desensitization procedure that has been used successfully as a control therapy in a seminal insomnia outcome study.37 The CTRL treatment also included education about sleep and sleep hygiene (to increase the credibility of the intervention to both therapists and patients) but it did not include any other active components of CBTI. The most recent practice parameters for the psychological and behavioral treatments of insomnia concluded that there is “insufficient evidence” for sleep hygiene education to be an
option as a single therapy.38 Both CBTI and CTRL therapies focused only on sleep; neither addressed mood, anhedonia, or other symptoms of depression. All participants were instructed to limit caffeine intake to the
However, although Qualitative research is valuable in providing descriptions and information on phenomena where we need initial explorations to develop new theories, generate and even test hypotheses, in my research study, all of the information that will be gathered will be of a quantitative nature because my study questions are looking for a cause and effect relationship. The study’s analysis will be represented into numerical and statistical analysis form. Quantitative research will be of great value to my study as several studies in insomnia and depression have focused, because it will provide a much deeper understanding of the relationship between insomnia and depression and current theories. Likewise, by testing the hypothesis or theory with the data collected, randomized trials will contributed to highlight the increased comorbidity between insomnia and depression and a range of other psychological disorders, such as anxiety disorders. The results will also highlight the importance of treating insomnia early in therapy and the risk to other disorders if insomnia remains untreated for a long time.
Reliability implies consistency: if you take a test five times, you should get roughly the same results every time. A test is valid if it measures what it’s supposed to.
Internal reliability, is a measure of how well your test is actually measuring what you want it to measure. In my study I will use HADS for measuring Depression and PSQI for severity of Insomnia Questionnaires which both have been proven to be very reliable in measuring what they supposed to be measuring.
External reliability means that a test or measure can be generalized beyond what we are using it for. For example, a test for depression should be able to detect depression or insomnia in different age groups, for people in different socio-economic statuses, or introverts which again HADS and PSQI have been proven to have external reliability. For this reason I will use secondary research; questionnaires and procedures that have been developed and used by others rather than creating my own.
As a result, my study will give me reliable and valid results that will be able to be generalised to the general population.
The main depression measures were the HRSD17 and the depression portion of the SCID, both administered at each study visit (at baseline and after 2, 4, 6, 8, and 12 weeks of treatment) by trained raters masked to participants’ treatment assignments. The intraclass correlation based on 22 HRSD interviews was 0.96. When examined symptom-by-symptom, the median intraclass correlation was 0.85. The main outcome measure was remission of MDD at study exit, which required both an HRSD17 -score ≤ 7 and absence of the 2 core symptoms of MDD.
Changes in sleep variables were measured with daily sleep diaries and actigraphs. The daily sleep diary provides data on bedtime, rise time, minutes to sleep onset latency, minutes awake after sleep onset, minutes awake before planned (early morning awakening), and subjective sleep quality. Actigraphs provide objective minute-by-minute data on sleep-wake states. An actigraph is a watch-size motion-recording apparatus that contains an acceleration sensor, a processor, and memory. The processor records physical motion and translates it to numerical digital data. Actigraphy provides an acceptable objective longitudinal measure of sleep continuity in natural settings.39 Each participant wore an Actiwatch™ by Minimitter daily on the nondominant wrist for 2 weeks at baseline, between weeks 6 and 8 (midpoint of treatment), and between weeks 14 and 16 (end of treatment). To increase the accuracy of scoring, participants noted in the diary the times that the event marker for onset and offset of the time in bed were pressed, and documented when the unit was not worn. The following measures, recorded and derived from the diary and actigraphy data, were analyzed: total wake time (TWT; summation of sleep onset latency, wake time after sleep onset, and early morning awakening), total sleep time (TST), sleep efficiency (SE; the ratio between TST and time in bed); and subjective sleep quality (diary only).
The clinical significance of the results was evaluated with the Insomnia Severity Index (ISI).36 This measure provides an index of the global severity of insomnia, including perceived daytime consequences and distress. It has good psychometric properties.40 The score range is between 0 and 28. Scores in the range 0 to 7 represent “no clinically significant insomnia”; scores in the range of 8 to 14 represent “sub-threshold insomnia”; scores in the range of 15 to 21 represent “clinical insomnia (moderate severity)”; and scores in the range 22 to 28 represent “clinical insomnia (severe).” The ISI was administered at baseline, treatment week 5, and at the end of treatment. Remission of insomnia was defined by an ISI score ≤ 7.
Expectations of benefit from treatment were completed independently by the therapists and patients after the second session, when the 2 therapies diverged. Patients’ expectations were measured with 4 items taken from the California Psychotherapy Alliance Scales (CALPAS)41,42 and the Session Evaluation Form (SEF).43 Since the items were not on the same scale, the average z-scores of the 4 items constituted the patient expectation score. Therapists’ expectations of benefit for their client were computed as the average of the following 2 items, both rated on a 5-point Likert scale: “Predict the likelihood that this patient will benefit from the particular treatment you are offering.” (1 = not very likely and 5 = very likely) and “How much do you expect this patient to improve by the end of the treatment?” (1 = not at all and 5 = very much).
To assess compliance with the CBTI recommendations, therapists rated each patient on a 5-point Likert scale as to how much each instruction was followed. The Likert scale was anchored as follows: 0 = poor/no compliance; 1 = marginal; 2 = fair; 3 = good; 4 = very good; 5 = excellent.
The instructions that were rated were as follows: (1) go to bed only when sleepy; (2) get out of bed when unable to sleep initially; (3) get out of bed when unable to sleep in the middle of the night; (4) wake up at prescribed time; (5) get out of bed shortly after waking up; (6) use bed and bedroom only for sleep. An overall compliance score was computed as the mean score of all items across all time points.
Participants who expressed initial interest in the study (N=763) were screened as follows: 1) a 15-min telephone screening interview was used to ensure basic study criteria were met; 2) in person interviews using the SCID, HRSD17, and the Duke Structured Interview for Sleep Disorders; 3) in-home polysomnography to determine RDI and PLMS index; 4) laboratory screens (thyroid and urine drug screen); 5) 2 weeks of sleep diaries to verify that research criteria for insomnia were met; and 6) a meeting with the study physician to ensure that there were no contra-indications for administering escitalopram. Qualified participants (N = 30) entered a 2 week baseline period, during which they completed sleep diaries and wore actigraphs. Participants were then randomized to EsCIT+CBTI (N = 15) or EsCIT + CTRL (N = 15). Randomization was performed in blocks of 2 and separate randomization tables were created for individuals with HRSD17 scores above and below 20 to ensure
equal distribution of depression severity in the two conditions. Treatment allocation was concealed from the principal investi-gator and all other investigators and personnel, except for the study coordinator, who assigned participants to their groups and indicated the assignment in the randomization table, and the psychotherapists. The participants, the psychiatrist managing the medications, and the clinical raters were masked to treatment conditions. Seasonal variations in light were unlikely to confound the results as CBTI and CTRL were both administered equally at the different times of the year.
Participant flow from enrollment until the end of treatment is depicted in Figure 1. The analyzable sample consisted of all randomized participants who attended at least one post randomization assessment visit (13 in EsCIT + CBTI and 15 in EsCIT + CTRL). Demographic and baseline characteristics of the sample with respect to depression and insomnia appear in Table 1. There were no group differences in any of the baseline variables depicted in Table 1.
Indication of Efficacy
EsCIT + CBTI resulted in a higher rate of remission from depression (61.5%) than EsCIT + CTRL (33.3%), but this large difference was not statistically significant (P = 0.13 for a one-tailed Fisher exact test). The mean baseline and endpoint HRSD17 scores and HRSD17 scores after removing the 3 sleep items, are depicted in Table 2 as are the Cohen’s-d effect sizes for the differential change in HRSD scores.
Participants’ expectations of sleep benefit, measured at the end of session 2 as the mean of the item z-scores, were -0.45 (0.64) for EsCIT + CBTI and -0.68 (0.70) for EsCIT + CTRL. The difference did not reach statistical significance (t = 0.88; P = 0.39; Cohen’s-d = 0.34). To test the impact of patients’ expectations on the main outcome we tested a logistic regression model with remission status as the dependent variable. The predictors included treatment group, patient expectations, both centered, and their interaction. The overall model fit was significant (χ2 = 9.4, P = 0.024). Of the variables in the model only the interaction term was significant (Wald = 4.5, P = 0.033). Follow up examination of the 4 subgroups based on split median of all patients’ expectations (CBTI-Low expectation, CBTI-High expectation, CTRL-Low expectation, CTRL-High Expectation) revealed that expectations played a significant role in the EsCIT + CTRL group, with 0% (0/9) of those with low expectation attaining remission status and 83% (5/6) of those with high expectations attaining remission status. In contrast, in the EsCIT + CBTI group, 80% (4/5) of those with low expectation remitted and only 43% (3/7) of those with high expectation remitted. Therapists’ expectations of benefit were significantly higher for participants in the EsCIT + CBTI group, 4.5 (0.49), than for those in the EsCIT + CTRL group, 3.5 (0.84) for CTRL (t = 3.5; P = 0.002; Cohen’s-d = 1.31) and were significantly correlated with patients’ expectations (r = 0.40, P < 0.05).
Impact on Sleep
Table 3 summarizes the pre- and post-treatment values for the ISI, sleep diary and actigraphy derived sleep parameters using the last available data. Participants in the CBTI group had larger improvement than those in CTRL group in all measures improvement in diary based sleep efficiency (SE) and the insomnia severity index (ISI). The proportion of participants who achieved insomnia remission (ISI score ≤ 7) at the last available observation was 50.0% in the EsCIT + CBTI group and 7.7% in the EsCIT + CTRL group (χ2 = 5.7, P = 0.05). The correlation between change in ISI scores and patients’ expectation of sleep benefits was significant (r = 0.49, P = 0.015). Higher expectations of benefit were associated greater reductions in ISI scores. Although there is not sufficient power to conduct a meaningful mediation analysis to determine if improvement in sleep mediated differential remission rates between the two insomnia therapies, we describe the relationship between remission form depression and remission from insomnia in the whole sample (combining both groups). Among those whose insomnia remitted 83% also experienced remission of depression, whereas among those whose insomnia did not remit only 39% experienced remission of depression (χ2 = 3.6, P = 0.08).
DISCUSSION Controlled trials have established the efficacy of CBT-I for primary insomnia.5,6 However, the relative efficacy of individual versus group treatment formats in real-world settings is not well established. The present study compared the short-term efficacy in a clinical setting between I-CBT-I and G-CBT-I for primary insomnia outpatients undergoing the same treatment components and providers. This trial represents the first attempt to compare different formats of CBT-I using actigraphy as the objective sleep measurement. As there is reportedly an underestimation of objective sleep evaluation and dissociations between subjective and objective evaluation of sleep in primary insomnia,22 it is important to evaluate the therapeutic changes in objective measurements. The findings in the present study complemented previous studies3,4,7 showing that CBT-I was effective treatment for primary insomnia. The comparison of pretreatment to post-treatment, as the short-term outcome, showed that CBT-I produced significant changes in many parameters. In the post-treatment measurements, subjective bedtime was delayed, subjective rising time was advanced, subjective TST increased, subjective and objective SOL shortened, objective TIB, WASO, and MT decreased, and objective SE increased. All of these suggested the improvement of nocturnal sleep after the treatment. At the same time, subjective evaluations of sleep quality and quantity improved, and the patients’ faulty cognition about sleep was corrected after the treatment. In the present study, different outcomes between I-CBT-I and G-CBT-I were shown. In regard to objective and subjective sleep onset latency time, objective sleep efficacy and moving time during sleeping, overall sleep quality and duration of actual sleep time in PSQI, the consequences of insomnia, control, and predictability of sleep, sleep requirement expectation, and sleeppromoting practices in DBAS, I-CBT-I resulted in larger improvements compared with G-CBT-I. Although these results were contrasted with the previous studies8,9,23 the present study suggested a slight superiority of I-CBT-I over G-CBT-I in the improvements of not only subjective but also objective sleep measurements. Furthermore, the superiority was remarkable in the correction of dysfunctional beliefs and attitudes about sleep. One reported advantage of I-CBT-I is its fit within traditional medical and mental health outpatient settings. I-CBT-I also allows maximum flexibility in tailoring treatment to best address each individual patient’s problematic sleeprelated cognition and behavior.6 On the other hand, G-CBT-I may afford patients less individualized attention.6 A possible explanation will be able to propose that patients who are more severely insomniac or socially anxious may generally find it harder to engage in group treatment, and therapists in a group setting may have less opportunity to address specific patient needs. Most previously described G-CBT-I protocols were typically provided in four to eight treatment sessions to a group of patients.6 Another explanation will be able to propose that numbers and hours spent in the sessions in this study may be insufficient. It will be important for future research to determine if individual and group CBT-I have a similar or different relationship to the maintenance of efficacy in routine clinical settings. Concerning CBT for depression, a clinical study that investigated outcome, costs, and patient engagement for group and individual CBT for depression mentioned that no significant differences were found in depressive symptoms between group and individual CBT at posttreatment and follow-up, and concluded that there were no differences between group differences in attrition or satisfaction.24 Another recent study that evaluated the effectiveness of group CBT compared to individual CBT for depressed outpatients mentioned that individual CBT was associated with larger effect sizes and signifi- cantly higher rates of recovery compared with group CBT.25 Regardless, systematic cost-effectiveness and cost-benefit comparisons between individual and group CBT for primary insomnia or depression have not yet been conducted. From a cost-effectiveness perspective, however, there are certainly advantages to implementing treatment in a group format.5,6 Future research should seek to replicate these findings under similar and controlled conditions, and to establish the comparative cost-effectiveness of each format of treatment. The present study has several limitations. The first limitations of the present study lie in the fact that there was no randomization for I-CBT-I and G-CBT-I. The periods of implements were also different for a few years. Not all of the present results can be considered to indicate the efficacy of CBT-I. All of the participants wished to receive CBT-I and therefore might have been very motivated. The second limitation lies in the fact that there was no control group. In the absence of a control group, it is impossible to rule out improvements over time. The third limitation lies in the fact that the authors could observe and compare only the short-term outcome. It is important to keep in mind and follow up on the fact that primary insomnia patients who benefit from short-term evaluation might remain vulnerable to recurrent insomnia episodes in the long term. In the present study, however, at 6 months after the treatment, sleep improvements and drug tapering achieved with G-CBT-I patients were well sustained.12 Although these limitations should be further discussed, in conclusion, the findings of the present study support the view that in a more clinically representative setting, I-CBT-I is a superior treatment format for primary insomnia compared to G-CBT-I.
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