Better Sleep in Psychiatric Care - Bipolar

NCT04130529 | Unknown

• 1 other identifier: 2018/80-31/1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Sleep Problem; Bipolar Disorder

Keywords

Cognitive Behaviour Therapy; Psychological Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• WHO Disability Assessment Schedule (WHODAS)

  Changes from base-line to 8 weeks, 5 months and 14 months

• Affective Self Rating Scale (AS-18)

  Changes from base-line to 8 weeks, 5 months and 14 months

• Sleep habits and behaviors

  Changes from base-line to 8 weeks, 5 months and 14 months

• Daytime Insomnia Symptoms

  Changes from base-line to 8 weeks, 5 months and 14 months

• Actigraphy

  Changes from base-line to post 8 weeks.

Study Arms (2)

Adjusted group CBT-i for Bipolar disorder

EXPERIMENTAL

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

Sleep lectures

ACTIVE COMPARATOR

The control group is offered a series of 3 lectures on sleep during the same time-period.

Other: Sleep lectures

Interventions

Adjusted group CBT-i for Bipolar disorder BEHAVIORAL

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.

Adjusted group CBT-i for Bipolar disorder

Sleep lectures OTHER

Lectures on the topic of sleep.

Sleep lectures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Night shift work

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (2)

Department of Affective Disorders, Northern Stockholm Psychiatry

Stockholm, 11321, Sweden

Location

Department of Affective Disorders, Stockholm Southwest Psychiatry

Stockholm, 14186, Sweden

Location

Related Publications (3)

• 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.

  PMID: 30399503 BACKGROUND

• 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.

  PMID: 25622197 BACKGROUND

• 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.

  PMID: 23820830 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Bipolar Disorder

Interventions

MD1

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Susanna Jernelöv, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 17, 2019
• Study Start: October 1, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)