Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Behavioral: Culturally adapted Psychoeducation (CaPE)
* Drug: Treatment as Usual (TaU)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Culturally adapted Psychoeducation (CaPE)<br> | Behavioral: Culturally adapted Psychoeducation (CaPE)<br>* 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.<br>|
| Active Comparator: Treatment as Usual (TaU)<br> | Drug: Treatment as Usual (TaU)<br>* This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | 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 | 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 | 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 | 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 | 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 |