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Dialogue to Empower Traditional and Faith Healers to Deliver mhGAP-IG Adapted Psychosocial Interventions in Kenya (Dialogue)

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mhGAP-IG
Sponsored by
Africa Mental Health Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Traditional healer, faith healer, depression, mhGAP, Kenya

Eligibility Criteria

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

Inclusion Criteria:

  1. Traditional and faith healers residing in Kibwezi West constituency
  2. Traditional and faith healers who are willing to participate in the study.
  3. Traditional and faith healers' patients' above 18 years who agree to participate in the study

Exclusion Criteria:

  1. Traditional and faith healers not residing in Kibwezi West constituency
  2. Traditional and faith healers who are not willing to participate in the study.
  3. Traditional and faith healers' patients' above 18 years who do not agree to sign an informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental arm

    Arm Description

    mhGAP-IG psychosocial intervention

    Outcomes

    Primary Outcome Measures

    Depression symptoms on the Becks Depression Inventory Scale
    Changes in depression scores (over time) on the Becks Depression Inventory Scale

    Secondary Outcome Measures

    Quality of life outcomes on the WHO Quality of Life-BREF (WHOQOL-BREF)
    Changes in quality of life domains using WHO Quality of Life-BREF (WHOQOL-BREF)

    Full Information

    First Posted
    May 22, 2017
    Last Updated
    May 23, 2017
    Sponsor
    Africa Mental Health Foundation
    Collaborators
    Grand Challenges Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03165513
    Brief Title
    Dialogue to Empower Traditional and Faith Healers to Deliver mhGAP-IG Adapted Psychosocial Interventions in Kenya
    Acronym
    Dialogue
    Official Title
    Dialogue to Empower, Supervise, Support and Include the Traditional and Faith Healers to Deliver Evidence-based mhGAP-IG Adapted Psychosocial Interventions to Reduce Treatment Gap in Kenya
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2014 (Actual)
    Primary Completion Date
    March 20, 2015 (Actual)
    Study Completion Date
    March 20, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Africa Mental Health Foundation
    Collaborators
    Grand Challenges Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The project aimed to create a dialogue between the informal sector (traditional and faith healers) and the formal sector (trained health care workers) in order to increase synergy and communication between the two systems, by minimizing any harmful practices and enhancing complementary practices. The informal sector will also be trained on how to use WHO mhGAP-IG component on depression for routine screening in order to ameliorate functional and social outcomes and refer complicated cases to the formal sector for biological interventions
    Detailed Description
    This study seeks to empower, supervise, support and include the informal traditional and faith healers to deliver evidence-based mhGAP-IG adapted psychosocial interventions to reduce mental health treatment gap in Kenya. This will be achieved through establishing a dialogue and collaboration between the formal and the informal sector and training the informal sector on the use of mental health Gap Action Programme Intervention Guideline (mhGAP-IG) to identify and manage depression. It will take place in Makueni County among 100 randomly selected TH/FH. A descriptive (prospective cohort) study will be used to determine the impact of training TH/FH on the use of mhGAP-IG in the identification and management of depression. A mental health specialist will also determine the accuracy of diagnosis made by the informal sector using randomly selected patients (true positives and true negatives for depression) by an independent person. Moreover, patients identified to have depression will be followed up at 6 and 12 weeks to assess their health outcomes using BECKs Depression Inventory Scale, Suicidality Scale and WHO quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder, Major
    Keywords
    Traditional healer, faith healer, depression, mhGAP, Kenya

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Descriptive study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    4081 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental arm
    Arm Type
    Experimental
    Arm Description
    mhGAP-IG psychosocial intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    mhGAP-IG
    Intervention Description
    psychosocial interventions
    Primary Outcome Measure Information:
    Title
    Depression symptoms on the Becks Depression Inventory Scale
    Description
    Changes in depression scores (over time) on the Becks Depression Inventory Scale
    Time Frame
    Baseline, 6 weeks and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of life outcomes on the WHO Quality of Life-BREF (WHOQOL-BREF)
    Description
    Changes in quality of life domains using WHO Quality of Life-BREF (WHOQOL-BREF)
    Time Frame
    baseline, 6 weeks and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Traditional and faith healers residing in Kibwezi West constituency Traditional and faith healers who are willing to participate in the study. Traditional and faith healers' patients' above 18 years who agree to participate in the study Exclusion Criteria: Traditional and faith healers not residing in Kibwezi West constituency Traditional and faith healers who are not willing to participate in the study. Traditional and faith healers' patients' above 18 years who do not agree to sign an informed consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christine W Musyimi, MSc
    Organizational Affiliation
    Africa Mental Health Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Deidentified data will be made available to the researchers on request through the principal investigator. A data request form available at AMHF will be used to make the request
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4705751/
    Description
    Forming a joint dialogue article
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/28251478
    Description
    Mental Health Outcomes of Psychosocial Intervention Among Traditional Health Practitioner Depressed Patients in Kenya.
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/28482849
    Description
    Quality of life of depressed and suicidal patients seeking services from traditional and faith healers in rural Kenya

    Learn more about this trial

    Dialogue to Empower Traditional and Faith Healers to Deliver mhGAP-IG Adapted Psychosocial Interventions in Kenya

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