Better Sleep in Psychiatric Care - Bipolar (BSIP-Bipolar)

Better Sleep in Psychiatric Care - Bipolar. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Bipolar Disorder

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 Bipolar disorder is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the Bipolar disorder. Other research groups have studied the use of behaviorally sleep treatments in patients with Bipolar disorder, but more studies are needed. 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 with more emphasis on achieving sleep promoting behaviors specific to Bipolar patients, for instance techniques that would also 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 patients with Bipolar disorder. 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 Bipolar symptoms in patients at the departments of Affective disorders, Northern Stockholm Psychiatry and Southwest Psychiatry, Stockholm, Sweden.

Study Overview

• Status: Completed
• Conditions: Bipolar Disorder; Sleep Problem
• Intervention / Treatment: Behavioral: Adjusted group CBT-i for Bipolar disorder; Other: Sleep lectures

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 11321
      • Department of Affective Disorders, Northern Stockholm Psychiatry
    • Stockholm, Stockholm County, Sweden, 14186
      • Department of 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 Bipolar disorder; The experimental group receives group-CBT-i adjusted for Bipolar disorder. This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the population with Bipolar Disorder. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the Bipolar population. Treatment is given as 8 weekly group sessions.	Behavioral: Adjusted group CBT-i for Bipolar disorder; CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. In addition components targeting circadian rhythm problems and problems with very high or very low levels of activity are included.
Active Comparator: Sleep lectures; The control group is offered a series of 3 lectures on sleep during the same time-period.	Other: Sleep lectures; Lectures on the topic of sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	7-item, self-rated questionnaire measuring change in 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
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
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
Affective Self Rating Scale (AS-18)	18-items self-report questionnaire measuring bipolar symptoms. Total score 0-72, subscale for depression (0-36), subscale for mania (0-36). Higher score indicates more severe symptoms.	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 other 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
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.
Sleep diary	Sleep diary based on the Core Consensus Sleep Diary. Participants report bedtime, sleep onset attempts, sleep onset latency, number and duration of nocturnal awakenings, wake-up time, rise time, and sleep quality (1-5). Two items from the Expanded Consensus Sleep Diary added, assessing sleep medication use during the night and level of morning refreshment/recovery (1-5). Diary to be completed each morning.	Two weeks pre-treatment, two weeks post-treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSQ-8	Treatment satisfaction assessed post-treatment using the Client Satisfaction Questionnaire (CSQ-8), an eight-item self-report measure with total scores ranging from 8 to 32, where higher scores indicate greater satisfaction.	Week 8 of treatment (i.e. post-treatment)
Side-effects	Side effects were assessed using a self-report checklist of 12 common side effects. Participants indicated whether each side effect was present and rated its interference with functioning on a 0-4 scale. Additional side effects could be reported and rated using the same scale.	Week 8 of treatment (i.e. post-treatment)
Adverse events	Adverse events, including clinically significant mood deterioration and major negative events (eg, hospitalisation), were reported by therapists throughout treatment.	Start of treatment until end of treatment (8 weeks)
TCS	Treatment credibility assessed using a five-item self-report scale adapted from the Credibility/Expectancy Questionnaire and Borkovec & Nau (total score 5-50; higher scores indicate greater credibility).	Week 3 of treatment
Need for additional care	Participants reported their need for additional sleep-related care, whether they intended to seek treatment, and what type of treatment they preferred.	Three-month follow-up

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Kaplan KA, Talavera DC, Harvey AG. Rise and shine: A treatment experiment testing a morning routine to decrease subjective sleep inertia in insomnia and bipolar disorder. Behav Res Ther. 2018 Dec;111:106-112. doi: 10.1016/j.brat.2018.10.009. Epub 2018 Oct 27.
• Harvey AG, Soehner AM, Kaplan KA, Hein K, Lee J, Kanady J, Li D, Rabe-Hesketh S, Ketter TA, Neylan TC, Buysse DJ. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial. J Consult Clin Psychol. 2015 Jun;83(3):564-77. doi: 10.1037/a0038655. Epub 2015 Jan 26.
• Kaplan KA, Harvey AG. Behavioral treatment of insomnia in bipolar disorder. Am J Psychiatry. 2013 Jul;170(7):716-20. doi: 10.1176/appi.ajp.2013.12050708.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): December 19, 2024

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Psychological Intervention; Cognitive Behaviour Therapy
• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Mood Disorders; Parasomnias; Bipolar Disorder; MD1
• Other Study ID Numbers: 2018/80-31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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