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

May 23, 2017 updated by: Africa Mental Health Foundation

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

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

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4081

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
mhGAP-IG psychosocial intervention
psychosocial interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression symptoms on the Becks Depression Inventory Scale
Time Frame: Baseline, 6 weeks and 12 weeks
Changes in depression scores (over time) on the Becks Depression Inventory Scale
Baseline, 6 weeks and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life outcomes on the WHO Quality of Life-BREF (WHOQOL-BREF)
Time Frame: baseline, 6 weeks and 12 weeks
Changes in quality of life domains using WHO Quality of Life-BREF (WHOQOL-BREF)
baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christine W Musyimi, MSc, Africa Mental Health Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

March 20, 2015

Study Completion (Actual)

March 20, 2015

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • P602/12/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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