Bipolar DisorderR-BipolarNCT06176001
Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder, a Randomized Controlled Trial
A study testing psychoeducation in groups in people with Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
Trial summary
Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- psychoeducation in groups
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Apr 2022to 1 Jun 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
- Relatives of patients with Bipolar Disorder who are affiliated with the Copenhagen Affective Disorder Clinic.
Who cannot join
- Insufficient Danish language.
- Age below 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder - a Large Scale Real-world Randomized Controlled Parallel Group Trial
Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. The investigators are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD.
The trial is designed as a two-arm, parallel group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. the investigators plan to include 200 relatives. The group sizes for psychoeducation is between 20-40 relatives.The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessment. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD.
- Conditions
- Bipolar Disorder
- Being tested
- psychoeducation in groups
- Keywords
- Relatives, Caregivers, Family, Psychoeducation, Randomized controlled trial
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychoeducation in groupsOther
Group-based psychoeducation for relatives. Group size: 20-40 relatives. Duration of intervention: six sessions, each two hours long with a 15 minutes break, over a period of 6-10 weeks. The sessions are held by experienced clinicians from the Copenhagen Affective Disorder Clinic, one chief physician and one nurse. Each session focuses on a specific topic, which the clinicians present and discuss using a presentation viewer. The sessions are interactive, and the participants are encouraged to ask questions during the presentations. During each session the participants will have some discussions in smaller groups to reflect on a topics and issues raised during the session.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Active comparator | Participants randomized to this arm are offered group-based psychoeducation shortly thereafter. Receives: Other: psychoeducation in groups |
| Waiting list | Placebo comparator | Participants randomized to this arm are placed on a waiting list for approximately 4 months and then offered group-based psychoeducation thereafter. Receives: Other: psychoeducation in groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mood instability in the relatives
Mood instability is calculated from daily self-reported mood registration in the app Monsenso. Participating relatives score their daily mood on a 9-point scale from 0-8 where 8 is 'in a brilliant mood' and 0 is 'really sad'
The participant rate daily in the Monsenso app during the time the participate in the study (4-8 months depending on which group they are randomly allocated to).
For each participant, a mood instability measure will be estimated for each day and aggregated by applying the root mean square successive difference (rMSSD) method.
Measured: daily in 4-8 months.
Change in mood instability in the corresponding patients
Mood instability is calculated from daily self-reported mood registration via the app Monsenso. The patients score their daily mood on a scale from -3 to +3, where -3 is the worst and +3 is the best mood. Patients' data from the Monsenso app is collected from a parallel RCT, in the time frame in which the relatives are in the study.
Measured: daily in 4-8 months.
Secondary outcomes (15)
Self-reported daily registrations in the Monsenso app on the following topics: daily activity level, sleep, mixed moods, anxiety, irritability, cognition, stress, alchohol consumption, patient support and level of burden from being a caregiver,
Each topic is covered by a single, simple question in the Monsenso app:
- Daily activity level: 'how active have you been?' (7-point scale from very little to very much)
- Sleep: How many hours did you sleep (scale from 0 to 12+hours)
- mixed moods: have you experienced mixed good and bad mood? (yes/no)
- Anxiety: Have you felt anxiety? (5-point scale from 'not at all' to 'to a high degree')
- Irritability:Have you felt irritable? (5-point scale, same as above)
- Cognition: Have you experienced cognitive difficulties? (5-point scale, same as above)
- Stress: Have you been stressed? (5-point scale, same as above)
- Alcohol: how many drinks have you had? (scale from 0 til 10+ drinks)
- Patient support: Have you helped or supported the patient? (5-point scale, same as above)
- Caregiver burden: To which degree have you experienced the patient's mental health problems as a burden to you? (5-point scale, same as above)
Measured: daily 4-8 months.
Self-rated caregiver burden
Burden Assessment Scale
19 questions covering subjects as economic and practical burden, stigma, worries, conflicts etc, participants answer on a scale from [1: not at all] to [4: to a high degree] or [not relevant]
Reinhard SC, Gubman GD, Horwitz AV, Minsky S. Burden assessment scale for families of the seriously mentally ill. Eval Program Plann. 1. juli 1994;17(3):261-9.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated expressed emotions
Perceived Criticism Measure
The questionnaire consists of four questions covering criticism in a relationship, answered on a scale from 0 to 10, where 10 is the highest and most negative.
Hooley JM, Parker HA. Measuring expressed emotion: An evaluation of the shortcuts. J Fam Psychol. september 2006;20(3):386-96.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated quality of life
Carer Quality of Life
7 multiple-answer questions and one Visual Analog Scale to evaluate quality of life in the light of being an informal caregiver.
Brouwer WBF, van Exel NJA, van Gorp B, Redekop WK. The CarerQol instrument: A new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations. Qual Life Res. 1. august 2006;15(6):1005-21.
Hoefman RJ, van Exel NJA, Looren de Jong S, Redekop WK, Brouwer WBF. A new test of the construct validity of the CarerQol instrument: measuring the impact of informal care giving. Qual Life Res. 2011;20(6):875-87.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated carer self-efficacy
Carer-Self-Efficacy
12 questions about self-efficacy as a caregiver for a person with Bipolar disorder. The questionnaire was originally developed for persons with bipolar disorder (Smith) and later Hubbard et al made a version for caregivers.
Smith LM, Erceg-Hurn DM, McEvoy PM, Lim L. Self-efficacy in bipolar disorder: Development and validation of a self-report scale. J Affect Disord. 1. februar 2020;262:108-17.
Hubbard AA, McEvoy PM, Smith L, Kane RT. Brief group psychoeducation for caregivers of individuals with bipolar disorder: A randomized controlled trial. J Affect Disord. august 2016;200:31-6.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Knowledge about bipolar
25 questions testing the factual knowledge about bipolar disorder.
"The Bipolar disorders knowledge scale", Trevor A. Stump and Marty L. Eng. Journal of Affective disorders, 2018-10-01, Volume 238, Pages 645-650.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated health related quality of life
Short Form-12 (54,55) 12 questions on health-related quality of life.
Christensen LN, Ehlers L, Larsen FB, Jensen MB. Validation of the 12 Item Short form Health Survey in a Sample from Region Central Jutland. Soc Indic Res. 1. november 2013;114(2):513-21.
Amir M, Lewin-Epstein N, Becker G, Buskila D. Psychometric properties of the SF-12 (Hebrew version) in a primary care population in Israel. Med Care. oktober 2002;40(10):918-28.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated mental health
The Brief Symptom Inventory (BSI: Derogatis, 1992), a 53-item self-report inventory of psychopathology and psychological distress, the BSI psychometric profile produces the same nine primary symptom dimensions produced by the SCL-90-R.
Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. august 1983;13(3):595-605.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated stress
Perceived Stress Scale
10 questions covering stress symptoms in the last month.
Cohen S. Perceived stress in a probability sample of the United States. I: The social psychology of health. Thousand Oaks, CA, US: Sage Publications, Inc; 1988. s. 31-67. (The Claremont Symposium on Applied Social Psychology).
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated bipolar symptoms
Mood Disorder Questionnaire
Hirschfeld RMA, Williams JBW, Spitzer RL, Calabrese JR, Flynn L, Keck PE, m.fl. Development and Validation of a Screening Instrument for Bipolar Spectrum Disorder: The Mood Disorder Questionnaire. Am J Psychiatry. november 2000;157(11):1873-5.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated depressive symptoms
Major Depression Inventory
Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 5. august 2015;15:190.
Bech P, Wermuth L. Applicability and validity of the Major Depression Inventory in patients with Parkinson's disease. Nord J Psychiatry. (52):305-10.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated Childhood trauma
Childhood Trauma Questionnaire (CTQ)
Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, m.fl. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. august 1994;151(8):1132-6.
Measured: Only at inclusion
Clinically observer rated Depressive symptoms
Depressive symptoms assessed by the Hamilton Depression Rating Scale-6 items (min. value = 0; max. value = 22, with higher values reflecting more depressive symptoms)
Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. februar 1960;23(1):56-62.
Measured: At inclusion, at 3-4 months and for the control-group also at 7-8 months.
Clinically observer rated Manic symptoms
Manic symptoms assessed by the Young Mania Rating Scale (min. value = 0; max. value = 60, with higher values reflecting more manic symptoms)
Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry J Ment Sci. november 1978;133:429-35.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Clinically observer rated General functioning
General functioning assessed by the Functional Assessment Short Test, a 24-item interviewer-administered interview concerning autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time (min. value = 0; max. value = 72, with higher values reflecting poorer function)
Rosa AR, Sánchez-Moreno J, Martínez-Aran A, Salamero M, Torrent C, Reinares M, m.fl. Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health CP EMH. 7. juni 2007;3:5.
Measured: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start7 Apr 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Vedel Kessing, Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Investigators
- Lars V Kessing, professor, Principal investigator, Copenhagen Psychiatric Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176001
- Sponsor's protocol ID
- P-2021-809
- Acronym
- R-Bipolar
- Status last verified
- Jun 2025
- First submitted
- 29 Nov 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stokholm JR, Waldemar AK, Kessing LV. Becoming diplomats with boundaries - a thematic analysis of relatives' experiences with group-based psychoeducation about bipolar disorder. BMC Psychiatry. 2025 Sep 1;25(1):843. doi: 10.1186/s12888-025-07219-y.
PubMed 40890647Stokholm JR, Vinberg M, Faurholt-Jepsen M, Kessing LV. Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder-a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT. Trials. 2024 May 23;25(1):342. doi: 10.1186/s13063-024-08172-z.
PubMed 38783322
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder - a Large Scale Real-world Randomized Controlled Parallel Group Trial
- ClinicalTrials.gov ID
- NCT06176001
- Acronym / sponsor ID
- R-Bipolar / P-2021-809
- Conditions
- Bipolar Disorder
- Keywords
- Relatives, Caregivers, Family, Psychoeducation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Dec 2023 (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.
Relatives of patients with bipolar disorder (BD) often experience emotional burden with stress, and depressive symptoms that again increases the likelihood of destabilization and relapses in the patient. The effects of group-based psychoeducation have not been investigated in large-scale real-world settings. The investigators are currently conducting a large-scale real-world randomized controlled parallel group trial (RCT) to test whether group-based psychoeducation for relatives to patients with BD improves mood instability and other critical outcomes in relatives and the corresponding patients with BD.
The trial is designed as a two-arm, parallel group randomized trial with a balanced randomization 1:1 to either group-based psychoeducation or a waiting list for approximately 4 months and subsequent group-based psychoeducation. the investigators plan to include 200 relatives. The group sizes for psychoeducation is between 20-40 relatives.The primary outcome measure is mood instability calculated based on daily smartphone-based mood self-assessment. Other relevant outcomes are measured, including patients' reported outcomes, assessing self-assessed burden, self-efficacy, and knowledge about BD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Active comparator | Other: psychoeducation in groupsParticipants randomized to this arm are offered group-based psychoeducation shortly thereafter. |
| Waiting list | Placebo comparator | Other: psychoeducation in groupsParticipants randomized to this arm are placed on a waiting list for approximately 4 months and then offered group-based psychoeducation thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Relatives of patients with Bipolar Disorder who are affiliated with the Copenhagen Affective Disorder Clinic.
Key exclusion criteria (2 listed)
- Insufficient Danish language.
- Age below 18 years.
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 |
|---|---|---|
| psychoeducation in groupsGroup-based psychoeducation for relatives. Group size: 20-40 relatives. Duration of intervention: six sessions, each two hours long with a 15 minutes break, over a period of 6-10 weeks. The sessions are held by experienced clinicians from the Copenhagen Affective Disorder Clinic, one chief physician and one nurse. Each session focuses on a specific topic, which the clinicians present and discuss using a presentation viewer. The sessions are interactive, and the participants are encouraged to ask questions during the presentations. During each session the participants will have some discussions in smaller groups to reflect on a topics and issues raised during the session. | Other | Psychoeducation, Waiting list |
Primary outcome
Change in mood instability in the relatives
Time frame: daily in 4-8 months.
Mood instability is calculated from daily self-reported mood registration in the app Monsenso. Participating relatives score their daily mood on a 9-point scale from 0-8 where 8 is 'in a brilliant mood' and 0 is 'really sad' The participant rate daily in the Monsenso app during the time the participate in the study (4-8 months depending on which group they are randomly allocated to). For each participant, a mood instability measure will be estimated for each day and aggregated by applying the root mean square successive difference (rMSSD) method.
Change in mood instability in the corresponding patients
Time frame: daily in 4-8 months.
Mood instability is calculated from daily self-reported mood registration via the app Monsenso. The patients score their daily mood on a scale from -3 to +3, where -3 is the worst and +3 is the best mood. Patients' data from the Monsenso app is collected from a parallel RCT, in the time frame in which the relatives are in the study.
15 secondary outcomes
Self-reported daily registrations in the Monsenso app on the following topics: daily activity level, sleep, mixed moods, anxiety, irritability, cognition, stress, alchohol consumption, patient support and level of burden from being a caregiver,
Time frame: daily 4-8 months.
Self-rated caregiver burden
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated expressed emotions
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated quality of life
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated carer self-efficacy
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Knowledge about bipolar
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated health related quality of life
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated mental health
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated stress
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated bipolar symptoms
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated depressive symptoms
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Self-rated Childhood trauma
Time frame: Only at inclusion
Clinically observer rated Depressive symptoms
Time frame: At inclusion, at 3-4 months and for the control-group also at 7-8 months.
Clinically observer rated Manic symptoms
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Clinically observer rated General functioning
Time frame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 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 26 Sep 2025.
- Derived from this study: PubMed 40890647Stokholm JR, Waldemar AK, Kessing LV. Becoming diplomats with boundaries - a thematic analysis of relatives' experiences with group-based psychoeducation about bipolar disorder. BMC Psychiatry. 2025 Sep 1;25(1):843. doi: 10.1186/s12888-025-07219-y.
- Derived from this study: PubMed 38783322Stokholm JR, Vinberg M, Faurholt-Jepsen M, Kessing LV. Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder-a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT. Trials. 2024 May 23;25(1):342. doi: 10.1186/s13063-024-08172-z.
- 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.
Lars V Kessing, professor principal investigator
Copenhagen Psychiatric Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing psychoeducation in groups in people with Bipolar Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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 1 inclusion and 2 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 26 Sep 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 in mood instability in the relatives (time frame: daily in 4-8 months.). 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 NCT06176001, which also lists 2 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 26 Sep 2025.