Depressive Disorder, MajorDialogueNCT03165513
Dialogue to Empower Traditional and Faith Healers to Deliver mhGAP-IG Adapted Psychosocial Interventions in Kenya
A study testing mhGAP-IG in people with Depressive Disorder, Major, run by Africa Institute of Mental and Brain Health (AFRIMEB).
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- mhGAP-IG
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,081 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2014to 20 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
Read the 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.
- Conditions
- Depressive Disorder, Major
- Being tested
- mhGAP-IG
- Keywords
- Traditional healer, faith healer, depression, mhGAP, Kenya
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhGAP-IGBehavioural
psychosocial interventions
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | mhGAP-IG psychosocial intervention Receives: Behavioral: mhGAP-IG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms on the Becks Depression Inventory Scale
Changes in depression scores (over time) on the Becks Depression Inventory Scale
Measured: Baseline, 6 weeks and 12 weeks
Secondary outcomes (1)
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)
Measured: baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 Jul 2014
- Primary completion20 Mar 2015
- Study completion20 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Descriptive study
- Masking
- None (open label)
- Enrolment
- 4,081 participants (actual)
Sponsor and investigators
- Lead sponsor
- Africa Institute of Mental and Brain Health (AFRIMEB)
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada
- Responsible party
- Sponsor
- Investigators
- Christine W Musyimi, MSc, Principal investigator, Africa Institute of Mental and Brain Health (AFRIMEB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165513
- Sponsor's protocol ID
- P602/12/2013
- Acronym
- Dialogue
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03165513
- Acronym / sponsor ID
- Dialogue / P602/12/2013
- Conditions
- Depressive Disorder, Major
- Keywords
- Traditional healer, faith healer, depression, mhGAP, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,081 participants (actual)
- Lead sponsor
- Africa Institute of Mental and Brain Health (AFRIMEB)University, hospital or other
- Collaborators
- Grand Challenges Canada
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 20 Mar 2015 (actual)
- Study completion
- 20 Mar 2015 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Descriptive study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Behavioral: mhGAP-IGmhGAP-IG psychosocial intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mhGAP-IGpsychosocial interventions | Behavioural | Experimental arm |
Primary outcome
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
1 secondary outcome
Quality of life outcomes on the WHO Quality of Life-BREF (WHOQOL-BREF)
Time frame: baseline, 6 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Forming a joint dialogue articleLink provided by the sponsor.
- Mental Health Outcomes of Psychosocial Intervention Among Traditional Health Practitioner Depressed Patients in Kenya.Link provided by the sponsor.
- Quality of life of depressed and suicidal patients seeking services from traditional and faith healers in rural KenyaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine W Musyimi, MSc principal investigator
Africa Institute of Mental and Brain Health (AFRIMEB)
Questions about this trial
What is this clinical trial studying?
A study testing mhGAP-IG in people with Depressive Disorder, Major, run by Africa Institute of Mental and Brain Health (AFRIMEB).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms on the Becks Depression Inventory Scale (time frame: Baseline, 6 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.