Psychoeducation for Patients With Bipolar Disorder in Rwanda

NCT04671225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2023-05-25

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Groups Psychoeducation

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.

BEHAVIORAL

Waiting-list

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

Sponsors & Collaborators

  • University of Rwanda

    collaborator OTHER
  • Mental Health Services in the Capital Region, Denmark

    collaborator OTHER
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per Kallestrup, Prof. · University of Aarhus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Rwanda

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671225 on ClinicalTrials.gov