Better Sleep in Psychiatric Care - Anxiety and Affective Disorders (BSIP-AAD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anxiety Disorders; Sleep Problem; Affective Disorder
• Intervention / Treatment: Behavioral: Adjusted group CBT-i for Anxiety and Affective disorders; Other: Care as usual wait-list control group

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 141 86
    • Program for Anxiety and Affective disorders, Stockholm Southwest Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjusted group CBT-i for Anxiety and Affective disorders; 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; 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.
Active Comparator: Care as usual wait-list control group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Susanna Jernelöv, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Psychological Intervention; Cognitive Behaviour Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Anxiety Disorders; Dyssomnias; Parasomnias; Mood Disorders
• Other Study ID Numbers: 2018/80-31/1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No