Bipolar DisorderNCT01704352
Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder
A study testing Cognitive behavioral therapy for insomnia in people with Bipolar Disorder and Insomnia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Insomnia
- What is being tested?
- Cognitive behavioral therapy for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2013to Aug 2018
- 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
- Fulfilling criteria for SCID-1-verified bipolar I or II disorder
- Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
- Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).
Who cannot join
- Being or having been in a defined affective episode the last month before inclusion
- Hospitalization in the last two months before inclusion
- Working night shifts
- Sleep apnea
- Medical conditions incompatible with participation.
- Inability to cooperate in the 3-week initial phase before randomization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.
- Conditions
- Bipolar Disorder, Insomnia
- Being tested
- Cognitive behavioral therapy for insomnia
- Keywords
- Cognitive Behavioral Therapy, CBT-I
- Medical subject headings
- Bipolar Disorder, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomniaBehavioural
CBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep. Receives: Behavioral: Cognitive behavioral therapy for insomnia |
| Treatment as usual | No intervention | Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of sleep at 8 weeks
As assessed by the Insomnia Severity Index (ISI)
Measured: At 8 weeks from randomization
Change from baseline in quality of sleep at 6 months follow-up
As assessed by the Insomnia Severity Index (ISI)
Measured: 6 months from end of treatment phase
Secondary outcomes (2)
Variation in sleep registration from baseline to 8 weeks
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
Measured: At 8 weeks
Variation in sleep registration from baseline to 6 months follow-up
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Gunnar Morken, PhD Prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704352
- Sponsor's protocol ID
- 2012/1033
- Status last verified
- Nov 2018
- First submitted
- 8 Oct 2012
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinan MK, Krane-Gartiser K, Langsrud K, Sand T, Kallestad H, Morken G. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial. Trials. 2014 Jan 16;15:24. doi: 10.1186/1745-6215-15-24.
PubMed 24433249
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01704352
- Acronym / sponsor ID
- 2012/1033
- Conditions
- Bipolar Disorder, Insomnia
- Keywords
- Cognitive Behavioral Therapy, CBT-I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jan 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 11 Oct 2012 (estimated)
- 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.
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: Cognitive behavioral therapy for insomniaCognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep. |
| Treatment as usual | No intervention | –Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fulfilling criteria for SCID-1-verified bipolar I or II disorder
- Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
- Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).
Key exclusion criteria (6 listed)
- Being or having been in a defined affective episode the last month before inclusion
- Hospitalization in the last two months before inclusion
- Working night shifts
- Sleep apnea
- Medical conditions incompatible with participation.
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 |
|---|---|---|
| Cognitive behavioral therapy for insomniaCBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I. | Behavioural | CBT-I |
Primary outcome
Change from baseline in quality of sleep at 8 weeks
Time frame: At 8 weeks from randomization
As assessed by the Insomnia Severity Index (ISI)
Change from baseline in quality of sleep at 6 months follow-up
Time frame: 6 months from end of treatment phase
As assessed by the Insomnia Severity Index (ISI)
2 secondary outcomes
Variation in sleep registration from baseline to 8 weeks
Time frame: At 8 weeks
Variation in sleep registration from baseline to 6 months follow-up
Time frame: At 6 months
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 20 Nov 2018.
- Derived from this study: PubMed 24433249Steinan MK, Krane-Gartiser K, Langsrud K, Sand T, Kallestad H, Morken G. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial. Trials. 2014 Jan 16;15:24. doi: 10.1186/1745-6215-15-24.
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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.
Gunnar Morken, PhD Prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy for insomnia in people with Bipolar Disorder and Insomnia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 6 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Change from baseline in quality of sleep at 8 weeks (time frame: At 8 weeks from randomization). The study lists 2 primary outcomes in all. 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 NCT01704352, which also lists 1 linked publication.
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 20 Nov 2018; AzTrials last refreshed its copy on 29 Oct 2026.