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NCT06176001Completed

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

Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder - a Large Scale Real-world Randomized Controlled Parallel Group Trial

Source: ClinicalTrials.gov · Last updated 26 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
206 (actual)
First submitted
29 Nov 2023
Start date
7 Apr 2022
Primary completion date
1 Jun 2024
Lead sponsor
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
NCT number
NCT06176001

What you commit to

  • Study type: Interventional
  • Participants enrolled: 206
  • From 7 Apr 2022 to the primary completion date, 1 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age below 18 years.

Other

  • Insufficient Danish language.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Copenhagen Affective Disorder Clinic
Coordinator of this site? Confirm its status
CopenhagenDenmarkUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.