Clinical trial NCT05721196: Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria
Official title: Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: Nottingham Trent University
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Teesside University
name: University of Manchester
First posted: 2023-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain reduction
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary outcomes:
measure: Bipolar knowledge and attitude
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Medication adherence
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Severity of mood symptoms
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
measure: Quality of life
timeFrame: Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Other outcomes:
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