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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04130529
Other study ID # 2018/80-31/1
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 2025

Study information

Verified date October 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 85
Est. completion date June 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
Other:
Sleep lectures
Lectures on the topic of sleep.

Locations

Country Name City State
Sweden Department of Affective Disorders, Northern Stockholm Psychiatry Stockholm
Sweden Department of 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)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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
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 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
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
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.
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