Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria
Primary Purpose
Bipolar Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culturally adapted Psychoeducation (CaPE)
Treatment as Usual (TaU)
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Culturally adapted Psychoeducation (CaPE)
Treatment as Usual (TaU)
Arm Description
Outcomes
Primary Outcome Measures
Pain reduction
Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain.
Secondary Outcome Measures
Bipolar knowledge and attitude
Bipolar knowledge and attitude would be assessed using the Bipolar Knowledge & attitude questionnaire
Medication adherence
Medication adherence would be assessed using the Morisky measure of medication adherence survey
Severity of mood symptoms
Severity of mood symptoms would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory
Quality of life
Quality of life would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D)
Full Information
NCT ID
NCT05721196
First Posted
January 31, 2023
Last Updated
March 18, 2023
Sponsor
Nottingham Trent University
Collaborators
University of Toronto, Teesside University, University of Manchester
1. Study Identification
Unique Protocol Identification Number
NCT05721196
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nottingham Trent University
Collaborators
University of Toronto, Teesside University, University of Manchester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Culturally adapted Psychoeducation (CaPE)
Arm Type
Experimental
Arm Title
Treatment as Usual (TaU)
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Culturally adapted Psychoeducation (CaPE)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Treatment as Usual (TaU)
Intervention Description
This group of patients will receive routine treatment, which in Nigeria means attending the outpatient clinic and taking prescribed medication.
Primary Outcome Measure Information:
Title
Pain reduction
Description
Patients' pain reduction would be assessed by the Visual Analogue Scale. For example, 0 = No pain and 10 = worst pain.
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Secondary Outcome Measure Information:
Title
Bipolar knowledge and attitude
Description
Bipolar knowledge and attitude would be assessed using the Bipolar Knowledge & attitude questionnaire
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Title
Medication adherence
Description
Medication adherence would be assessed using the Morisky measure of medication adherence survey
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Title
Severity of mood symptoms
Description
Severity of mood symptoms would be assessed using the Young Mania Rating Scale (YMRS) or Beck's Depression Inventory
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
Title
Quality of life
Description
Quality of life would be assessed using the Health-related quality of life was also measured using EuroQoL (EQ-5D)
Time Frame
Change is being assessed at baseline, at 12 weeks end of intervention, at 3-months, and at 6-months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Culturally Adapted Psychoeducation (CaPE) for Bipolar Disorders in Nigeria
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