Clinical trial NCT04130529: Better Sleep in Psychiatric Care - Bipolar
Official title: Better Sleep in Psychiatric Care - Bipolar. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sleep Problem
Bipolar Disorder
Keywords: Cognitive Behaviour Therapy
Psychological Intervention
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2019-10-17
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
Secondary outcomes:
measure: WHO Disability Assessment Schedule (WHODAS)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Affective Self Rating Scale (AS-18)
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Sleep habits and behaviors
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Daytime Insomnia Symptoms
timeFrame: Changes from base-line to 8 weeks, 5 months and 14 months
measure: Actigraphy
timeFrame: Changes from base-line to post 8 weeks.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Affective Disorders, Northern Stockholm Psychiatry
city: Stockholm
country: Sweden
facility: Department of Affective Disorders, Stockholm Southwest Psychiatry
Study officials:
affiliation: Karolinska Institutet
name: Susanna Jernelöv, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.