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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Sleep Problem, Bipolar Disorder
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sleep lectures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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.
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.
- First posted17 Oct 2019
- Study start1 Oct 2019
- Primary completion28 Mar 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Susanna Jernelöv, Karolinska Institutet
- Investigators
- Susanna Jernelöv, PhD, Principal investigator, Karolinska Institutet
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 30399503Harvey 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 25622197Kaplan 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04130529
- Acronym / sponsor ID
- BSIP-Bipolar / 2018/80-31/1
- Conditions
- Sleep Problem, Bipolar Disorder
- Keywords
- Cognitive Behaviour Therapy, Psychological Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 17 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjusted group CBT-i for Bipolar disorder | Experimental | Behavioral: Adjusted group CBT-i for Bipolar disorderThe 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. |
| Sleep lectures | Active comparator | Other: Sleep lecturesThe control group is offered a series of 3 lectures on sleep during the same time-period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Night shift work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjusted group CBT-i for Bipolar disorderCBT-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. | Behavioural | Adjusted group CBT-i for Bipolar disorder |
| Sleep lecturesLectures on the topic of sleep. | Other | Sleep lectures |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Changes from base-line to 8 weeks, 5 months and 14 months
7-item, self-rated questionnaire measuring change in insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
6 secondary outcomes
WHO Disability Assessment Schedule (WHODAS)
Time frame: Changes from base-line to 8 weeks, 5 months and 14 months
Affective Self Rating Scale (AS-18)
Time frame: Changes from base-line to 8 weeks, 5 months and 14 months
Sleep habits and behaviors
Time frame: Changes from base-line to 8 weeks, 5 months and 14 months
Daytime Insomnia Symptoms
Time frame: Changes from base-line to 8 weeks, 5 months and 14 months
Actigraphy
Time frame: Changes from base-line to post 8 weeks.
Sleep diary
Time frame: Two weeks pre-treatment, two weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 30399503Kaplan 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.
- Background: PubMed 25622197Harvey 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.
- Background: PubMed 23820830Kaplan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna Jernelöv, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
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 last refreshed its copy on 6 Nov 2026.