Clinical trial NCT06176001: Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder, a Randomized Controlled Trial
Official title: Group-based Psychoeducation for Relatives of Patients With Bipolar Disorder - a Large Scale Real-world Randomized Controlled Parallel Group Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Keywords: Relatives
Caregivers
Family
Psychoeducation
Randomized controlled trial
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2023-12-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in mood instability in the relatives
timeFrame: daily in 4-8 months.
measure: Change in mood instability in the corresponding patients
timeFrame: daily in 4-8 months.
Secondary outcomes:
measure: 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,
timeFrame: daily 4-8 months.
measure: Self-rated caregiver burden
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated expressed emotions
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated quality of life
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated carer self-efficacy
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Knowledge about bipolar
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated health related quality of life
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated mental health
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated stress
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated bipolar symptoms
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated depressive symptoms
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Self-rated Childhood trauma
timeFrame: Only at inclusion
measure: Clinically observer rated Depressive symptoms
timeFrame: At inclusion, at 3-4 months and for the control-group also at 7-8 months.
measure: Clinically observer rated Manic symptoms
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
measure: Clinically observer rated General functioning
timeFrame: at inclusion, at follow-up around 4 months, and if in control group at around 7-8 months
Other outcomes:
measure: Change in automatically smarthone-generated data
timeFrame: 4-8 months
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Affective Disorder Clinic
Study officials:
affiliation: Copenhagen Psychiatric Center
name: Lars V Kessing, professor
role: PRINCIPAL_INVESTIGATOR
References: