Dialogue to Empower Traditional and Faith Healers to Deli... | NCT03165513

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

NCT03165513

Sponsor

Africa Institute of Mental and Brain Health (AFRIMEB)

Status

Completed

Last Update Posted

May 24, 2017Actual

Enrollment

4,081Actual

Phase

Not Applicable

Conditions

Depressive Disorder, Major

Interventions

mhGAP-IG

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2014Actual

Primary Completion Date

Mar 20, 2015Actual

Completion Date

Mar 20, 2015Actual

First Submitted Date

May 22, 2017

First Submission Date that Met QC Criteria

May 23, 2017

First Posted Date

May 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2017

Last Update Posted Date

May 24, 2017Actual

Name	Class
Grand Challenges Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4,081Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental arm	Experimental	mhGAP-IG psychosocial intervention	Behavioral: mhGAP-IG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mhGAP-IG	Behavioral	psychosocial interventions	Experimental arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine W Musyimi, MSc	Africa Institute of Mental and Brain Health (AFRIMEB)	Principal Investigator

Locations

Not provided

References Module

Citations

Not provided

Label	URL
Forming a joint dialogue article	View source
Mental Health Outcomes of Psychosocial Intervention Among Traditional Health Practitioner Depressed Patients in Kenya.	View source
Quality of life of depressed and suicidal patients seeking services from traditional and faith healers in rural Kenya

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression