Better Sleep in Psychiatric Care - Anxiety and Affective Disorders

Anxiety Disorders Clinical Trial

— BSIP-AAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04136054
• Other study ID #: 2018/80-31/1.1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 25, 2019
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorder
• Anxiety Disorders
• Dyssomnias
• Mood Disorders
• Parasomnias
• Sleep Problem

Intervention

Behavioral:
• Adjusted group CBT-i for Anxiety and Affective disorders
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.

Other:
• Care as usual wait-list control group
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.

Locations

Country	Name	City	State
Sweden	Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Blom K, Jernelov S, Kraepelien M, Bergdahl MO, Jungmarker K, Ankartjarn L, Lindefors N, Kaldo V. Internet treatment addressing either insomnia or depression, for patients with both diagnoses: a randomized trial. Sleep. 2015 Feb 1;38(2):267-77. doi: 10.5665/sleep.4412. — View Citation

Jansson-Frojmark M, Norell-Clarke A. Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. Curr Sleep Med Rep. 2016;2(4):233-240. doi: 10.1007/s40675-016-0055-y. Epub 2016 Oct 20. — View Citation

Ohayon MM, Roth T. Place of chronic insomnia in the course of depressive and anxiety disorders. J Psychiatr Res. 2003 Jan-Feb;37(1):9-15. doi: 10.1016/s0022-3956(02)00052-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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