AzTrials
AzTrials

Sleep ProblemBSIP-BipolarNCT04130529

Better Sleep in Psychiatric Care - Bipolar

A study testing Adjusted group CBT-i for Bipolar disorder and Sleep lectures in people with Sleep Problem and Bipolar Disorder, run by Karolinska Institutet at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Problem, Bipolar Disorder
What is being tested?
Adjusted group CBT-i for Bipolar disorder and Sleep lectures
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
2 sitesSweden
Study dates
1 Oct 2019to 19 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Night shift work

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Department of Affective Disorders, Northern Stockholm Psychiatry

    Stockholm, Stockholm County, 11321

  • Department of Affective Disorders, Stockholm Southwest Psychiatry

    Stockholm, Stockholm County, 14186

Other trials in Sweden

About this study

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

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.

Being tested
Adjusted group CBT-i for Bipolar disorder, Sleep lectures
Keywords
Cognitive Behaviour Therapy, Psychological Intervention
Medical subject headings
Parasomnias, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adjusted group CBT-i for Bipolar disorderBehavioural

    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.

  • Sleep lecturesOther

    Lectures on the topic of sleep.

Study groups in NCT04130529
Study groupRoleWhat they receive
Adjusted group CBT-i for Bipolar disorderExperimentalThe 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.
Receives: Behavioral: Adjusted group CBT-i for Bipolar disorder
Sleep lecturesActive comparatorThe control group is offered a series of 3 lectures on sleep during the same time-period.
Receives: Other: Sleep lectures

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. WHO Disability Assessment Schedule (WHODAS)

    12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: Changes from base-line to post 8 weeks.

  6. 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.

    Measured: Two weeks pre-treatment, two weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2019
  2. Study start1 Oct 2019
  3. Primary completion28 Mar 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04130529
Sponsor's protocol ID
2018/80-31/1
Acronym
BSIP-Bipolar
Status last verified
Jul 2026
First submitted
11 Oct 2019
Last updated
10 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30399503

  • 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.

    PubMed 25622197

  • 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.

    PubMed 23820830

Questions about this trial

What is this clinical trial studying?

A study testing Adjusted group CBT-i for Bipolar disorder and Sleep lectures in people with Sleep Problem and Bipolar Disorder, run by Karolinska Institutet at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: Changes from base-line to 8 weeks, 5 months and 14 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04130529, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in