NCT03165513

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,081

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

9 months

First QC Date

May 22, 2017

Last Update Submit

May 23, 2017

Conditions

Keywords

Traditional healerfaith healerdepressionmhGAPKenya

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Quality of life outcomes on the WHO Quality of Life-BREF (WHOQOL-BREF)

    baseline, 6 weeks and 12 weeks

Study Arms (1)

Experimental arm

EXPERIMENTAL

mhGAP-IG psychosocial intervention

Behavioral: mhGAP-IG

Interventions

mhGAP-IGBEHAVIORAL

psychosocial interventions

Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Christine W Musyimi, MSc

    Africa Institute of Mental and Brain Health (AFRIMEB)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Descriptive study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

July 1, 2014

Primary Completion

March 20, 2015

Study Completion

March 20, 2015

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share

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