CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 154 enrolled
Drug / intervention
Groups Psychoeducation +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04671225
NCT04671225N/ACompleted

Psychoeducation for Patients With Bipolar Disorder in Rwanda

University of Aarhus·interventional·Posted Dec 17, 2020·Updated May 25, 2023

In Brief

A clinical study evaluating Groups Psychoeducation and Waiting-list for Bipolar Disorder. Completed, enrolled 154 participants across 2 sites.

Detailed Summary

Background: Mental health- and neurological disorders constitute 13% of the global burden of disease. Alarmingly this burden has risen by 41% in the last 20 years. In low-and-middle-income countries as few as 10% of people living with bipolar disorder receive care. In western countries, the efficacy of psychoeducation, as an add-on treatment to pharmacotherapy in the treatment of symptoms and in relapse prevention initiatives with respect to bipolar disorder, is well documented. Yet, few studies on psychosocial interventions for bipolar disorder have been conducted in a low-income country. Aim: To determine the effect, feasibility and acceptability of psychoeducation for patients with bipolar disorder on all three levels of the health care system in Rwanda - at the community health centre, district- and university hospital. Methods: Patients will be randomized into either group A) group-psychoeducation at a referral hospital; or B) group-psychoeducation for both patients and relatives or C) waiting list. Moreover a district trial will test the impact and feasibility of psychoeducation at the district level. Outcomes: Reduction in symptom severity and incidence of relapse, improved quality of life, medical adherence and knowledge, as well as reduced self-stigmatization. Perspectives: If proven successful, this is of importance for closing the huge treatment gap in mental health particularly affecting low- and middle-income countries and may reduce the mortality and increase quality of life in the population suffering from bipolar disorder. Furthermore, potential positive outcomes may be implemented in similar low-resource settings elsewhere.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesRwanda

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 17, 2020
Enrollment StartJan 15, 2021
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.5 years ago

Interventions

Groups Psychoeducationbehavioral

Manual-structured group psychoeducation with 8 sessions of 90 minutes over the course of 8 weeks (at one session per week). The manual is centred on behavioural principles from social education and self-regulation philosophies. All groups will have 6-8 participants and two health professionals to conduct the sessions; a psychiatric nurse and either a psychologist or a psychiatric resident. Patients will be offered to invite their relatives for 2-3 psychoeducation-days for relatives.

Waiting-listbehavioral

Participants in the control group will be assigned to a waiting list and receive group-psychoeducation after the active intervention groups.