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

Mental Health Services in the Capital Region, Denmark

Status: Completed

Conditions: Bipolar Disorder

Treatments: Other: psychoeducation in groups

Study type: Interventional

Funder types: Other

Identifiers

NCT06176001

P-2021-809

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Insufficient Danish language.
• Age below 18 years.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

206 participants in 2 patient groups, including a placebo group

Psychoeducation

Active Comparator group

Description:

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

Treatment:

Other: psychoeducation in groups

Waiting list

Placebo Comparator group

Description:

Participants randomized to this arm are placed on a waiting list for approximately 4 months and then offered group-based psychoeducation thereafter.

Treatment:

Other: psychoeducation in groups