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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
Nottingham Trent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 31, 2023
    Last Updated
    March 18, 2023
    Sponsor
    Nottingham Trent University
    Collaborators
    University of Toronto, Teesside University, University of Manchester
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    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

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