Better Sleep in Psychiatric Care - Depression, Anxiety and PTSD

Not Applicable

Active, not recruiting

• Conditions: Sleep Problem; Anxiety Disorders; Affective Disorder
• Interventions: Other: Care as usual wait-list control group; Behavioral: Adjusted group CBT-i for Depression, Anxiety and PTSD

• Registration Number: NCT04136054
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-09-25
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-23
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2024-11
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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

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Exclusion Criteria

• Night shift work

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care as usual wait-list control group	Care as usual wait-list control group	Treatment as Usual. (After about five months, participants in this condition are offered the experimental group treatment.)
Adjusted group CBT-i for Depression, Anxiety and PTSD	Adjusted group CBT-i for Depression, Anxiety and PTSD	Cognitive Behavioral group intervention for sleep problems in patients with Depression, Anxiety and PTSD, based on Cognitive Behavioral Therapy for insomnia

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	Changes from base-line to 8 weeks, 5 months and 14 months	9-items self-rating questionnaire measuring level of depression. Total score 0-27 with higher score indicating more severe depression
Generalized Anxiety Disorder 7-item scale (GAD-7)	Changes from base-line to 8 weeks, 5 months and 14 months	7-item self-rating questionnaire measuring level of anxiety. Total score 0-21 with higher score indicating more severe anxiety.
Sleep habits and behaviors	Changes from base-line to 8 weeks, 5 months and 14 months	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.
Actigraphy	Changes from base-line to post 8 weeks	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.
Daytime Insomnia Symptoms	Changes from base-line to 8 weeks, 5 months and 14 months	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.
WHO Disability Assessment Schedule (WHODAS)	Changes from base-line to 8 weeks, 5 months and 14 months	12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.

Trial Locations

Locations (1)

Program for Affective disorders, Anxiety and Trauma, Stockholm Southwest Psychiatry; 🇸🇪 Stockholm, Sweden