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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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 PTSD, Anxiety disorders and Depression 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 mixed psychiatric 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 large withing-group 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 depressive symptoms in patients at the units for Anxiety and Affective disorders and Trauma, Southwest Psychiatry and Northern Stockholm Psychiatry, Stockholm County Council, Sweden.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjusted group CBT-i for Depression, Anxiety and PTSD | Experimental | Cognitive Behavioral group intervention for sleep problems in patients with Depression, Anxiety and PTSD, based on Cognitive Behavioral Therapy for insomnia |
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| Care as usual wait-list control group | Active Comparator | Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjusted group CBT-i for Depression, Anxiety and PTSD | Behavioral | Adjusted group CBT-i for Depression, Anxiety and PTSD. 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanna Jernelöv, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Program for Affective disorders, Anxiety and Trauma, Stockholm Southwest Psychiatry | Stockholm | 141 86 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36085009 | Background | Cassel M, Blom K, Gatzacis J, Renblad P, Kaldo V, Jernelov S. Clinical feasibility of cognitive behavioural therapy for insomnia in a real-world mixed sample at a specialized psychiatric outpatient clinic. BMC Psychiatry. 2022 Sep 9;22(1):600. doi: 10.1186/s12888-022-04231-4. |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| Care as usual wait-list control group | Other | 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, such as mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy. |
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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 |