Better Sleep in Psychiatric Care - Anxiety and Affective Disorders

Study Overview
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Brief Summary
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Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with Anxiety disorders and Affective disorders display high levels of sleep difficulties. Sleep problems are often general, such as insomnia and sleep phase problems. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this population. The basis was CBT for insomnia (CBT-i), but also including techniques that would alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in psychiatric patients. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and anxiety and affective symptoms in patients at the program for Anxiety and Affective disorders, Southwest Psychiatry, Stockholm County Council, Sweden.

Official Title
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Better Sleep in Psychiatric Care - Anxiety and Affective Disorders. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Anxiety and Affective Disorders

Conditions
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Sleep Problem, Anxiety Disorders, Affective Disorder

Intervention / Treatment
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* Behavioral: Adjusted group CBT-i for Anxiety and Affective disorders
* Other: Care as usual wait-list control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a patient at the clinics involved in the project Experiencing sleep problems (subjective report) Being able to participate in a psychological intervention in group format Exclusion Criteria: Night shift work

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjusted group CBT-i for Anxiety and Affective disorders<br>Cognitive Behavioral group intervention for sleep problems in patients with Anxiety and Affective disorders, based on Cognitive Behavioral Therapy for insomnia | Behavioral: Adjusted group CBT-i for Anxiety and Affective disorders<br>* Adjusted group CBT-i for Anxiety and Affective disorders. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment.<br>|
| Active Comparator: Care as usual wait-list control group<br>Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.) | Other: Care as usual wait-list control group<br>* Usual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity Index (ISI) | 7-item, self-rated questionnaire measuring insomnia severity. Total score 0-28, higher score indicates more severe sleep problems. | Changes from base-line to 8 weeks, 5 months and 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actigraphy | An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data. | Changes from base-line to post 8 weeks | 
| WHO Disability Assessment Schedule (WHODAS) | 12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Patient Health Questionnaire (PHQ-9) | 9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Generalized Anxiety Disorder 7-item scale (GAD-7) | 7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Sleep habits and behaviors | Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as Last week I got out of bed within 15 minutes of waking up to be answered by number of days the last week this was true (i.e. from 0 to 7). The second part is to be answered on a 6-point Likert scale from Not at all true to Entirely true, with 7 statements like I get out of bed the same time every morning. No total score is obtained. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Daytime Insomnia Symptoms | 7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms. | Changes from base-line to 8 weeks, 5 months and 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behaviour Therapy, Psychological Intervention