Psychoeducation for Patients With Bipolar Disorder in Rwanda

NCT04671225 | Completed

• 1 other identifier: AUUR2020DKRW
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 2

Brief 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

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Number of patients that relapse

  Relapse is defined as a new mood episode of mania (scores above or equal to 20 on the Young Mania Rating Scale (YMRS)(25)), hypomania (above or equal to 12 on the YMRS), or depression (above or equal to 17 on the Hamilton Depression Scale- 17(HDRS-17(26)) or mixed episode (above or equal to 20 on the YMRS and 12 on the HDRS- 17).

  1 year

Secondary Outcomes (4)

• Number of patient reporting improvement in medical adherence

  1 year

• Number of patient reporting reduction in self-stigma

  1 year

• Improvement of illness severity

  1 year

• Acceptability of the intervention

  1 year

Study Arms (2)

Intervention - Psychoeducation at the referral hospital

EXPERIMENTAL

Intervention: Manual-structured group psychoeducation.

Behavioral: Groups Psychoeducation

Waiting list - at the referral hospital

OTHER

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

Behavioral: Waiting-list

Interventions

Groups Psychoeducation BEHAVIORAL

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.

Intervention - Psychoeducation at the referral hospital

Waiting-list BEHAVIORAL

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

Waiting list - at the referral hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of BD type I or II that meets DSM-V diagnostic criteria given by a trained psychiatrist
• No episode in the preceding 4 weeks. Age ≥ 18 years.

You may not qualify if:

• Previous participation in any structured psychological intervention
• Insufficient understanding of Kinyarwanda
• Clinical evidence of substantial cognitive impairments.
• Alcohol or drug-dependence

Sponsors & Collaborators

• University of Aarhus: lead
• University of Rwanda: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (2)

Ndera Hospital

Kigali, Rwanda

Location

The University Teaching Hospital of Kigali (CHUK)

Kigali, Rwanda

Location

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Related Links

• WHO. Global Health Estimates 2016: Burden of disease by cause, age, sex, by country and by region, 2000-2016. 2018.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Per Kallestrup, Prof.

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The RCT: Outpatients from the two-referral hospitals in Rwanda will be invited to participate and be allocated to the intervention group or waiting list. The district trial: This trial compares the impact of the intervention given at the district level with the intervention conducted at the referral hospital. Randomization: Study participants at the hospital level who meet the inclusion criteria and sign the informed consent form will be randomized individually into either intervention-arm or waiting list through block-randomization with a ratio of 1:1. Patients at the district level will not be randomized since we are unsure of the number of patients with Bipolar Disorder at these levels fearing that the sample size will be too small. Instead, all will be offered participation.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 17, 2020
• Study Start: January 15, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 25, 2023

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

RW (2)