Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder, a Randomized Controlled Trial

NCT06176001 | Completed

• 1 other identifier: P-2021-809
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Relatives; Caregivers; Family; Psychoeducation; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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,

  daily 4-8 months.

• Self-rated caregiver burden

  at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months

• Self-rated expressed emotions

  at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months

• Self-rated quality of life

  at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months

• Self-rated carer self-efficacy

  at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months

Other Outcomes (1)

• Change in automatically smarthone-generated data

  4-8 months

Study Arms (2)

Psychoeducation

ACTIVE COMPARATOR

Participants randomized to this arm are offered group-based psychoeducation shortly thereafter.

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.

Other: psychoeducation in groups

Interventions

psychoeducation in groups OTHER

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.

Psychoeducation; Waiting list

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Relatives of patients with Bipolar Disorder who are affiliated with the Copenhagen Affective Disorder Clinic.

You may not qualify if:

• Insufficient Danish language.
• Age below 18 years.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

Copenhagen Affective Disorder Clinic

Copenhagen, 2000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 40890647 DERIVED

• Stokholm 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.

  PMID: 38783322 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Lars V Kessing, professor

  Copenhagen Psychiatric Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 19, 2023
• Study Start: April 7, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)