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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03165513
Other study ID # P602/12/2013
Secondary ID
Status Completed
Phase N/A
First received May 22, 2017
Last updated May 23, 2017
Start date July 1, 2014
Est. completion date March 20, 2015

Study information

Verified date May 2017
Source Africa Mental Health Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 4081
Est. completion date March 20, 2015
Est. primary completion date March 20, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
mhGAP-IG
psychosocial interventions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Africa Mental Health Foundation Grand Challenges Canada

Outcome

Type Measure Description Time frame Safety issue
Primary Depression symptoms on the Becks Depression Inventory Scale Changes in depression scores (over time) on the Becks Depression Inventory Scale Baseline, 6 weeks and 12 weeks
Secondary 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) baseline, 6 weeks and 12 weeks
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