Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria

March 18, 2023 updated by: Dr Dung Jidong, PhD, Nottingham Trent University

Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria: A Pilot Randomised Controlled Trial

Bipolar disorders are chronic mental health disorders that often result in functional impairment, constituting a significant disease burden. It also accounts for seven per cent of disability-adjusted life years caused by mental disorders. Four out of ten persons with a probable diagnosis of bipolar disorders received no mental health care within the preceding twelve months. Compared to the general population, individuals with bipolar disorders tend to have a significantly higher rate of associated suicide mortality. Within the last decade, these mortality rates have substantially increased, suggesting the need for targeted research to address the unresolved needs of individuals suffering from bipolar disorders. A recent meta-analysis found that compared to the general population, bipolar patients had reduced life expectancy with about thirteen years of potential life loss.

Bipolar disorders are historically under-researched compared to other mental health disorders, especially in Sub-Saharan Africa and Nigeria. Our recent study on bipolar disorders in Nigeria provided insight into contextual knowledge and beliefs about bipolar disorders, including the lived experiences of patients with bipolar disorders, their caregivers, and clinicians in Nigeria. The study recommended culturally adapted psychosocial intervention for bipolar patients, hence the proposed research.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosis of DSM IV bipolar affective disorder
  • currently euthymic (BDI < 12 and YMRS < 8)
  • age 18-65 years, participants engaged with the mental health services for the preceding 6 months
  • able to give written informed consent
  • resident of the trial catchment area and
  • the ability to speak English.

Exclusion Criteria:

  • severe cognitive impairment
  • currently experiencing relapse (mania, hypomania, mixed or depressive)
  • being actively suicidal
  • the presence of any comorbid psychiatric illness such as substance misuse or alcohol dependence according to DSM IV criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally adapted Psychoeducation (CaPE)
Behavioral: Culturally adapted Psychoeducation (CaPE)
This intervention consisted of 12 psychoeducation sessions, one session per week, that would be administered on an individual patient basis and to be added to treatment as usual. Each session lasted for approximately 1 h, beginning with a 20-30 min presentation on the topic of the day, followed by a related exercise (e.g., drawing a life chart or compiling a list of potential triggers for relapse). The content is a reduced and modified version of the Barcelona Psychoeducation Program for bipolar disorders.
Active Comparator: Treatment as Usual (TaU)
Drug: Treatment as Usual (TaU)
This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain.
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bipolar knowledge and attitude
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Bipolar knowledge and attitude would be assessed using the Bipolar Knowledge & attitude questionnaire
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Medication adherence
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Medication adherence would be assessed using the Morisky measure of medication adherence survey
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Severity of mood symptoms
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Severity of mood symptoms would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Quality of life
Time Frame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Quality of life would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D)
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham Trent University

Collaborators

University of Toronto
University of Manchester
Teesside University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

July 30, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 18, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-0001-5034-0335e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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