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Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia

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ClinicalTrials.gov Identifier: NCT03458039
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Johns Hopkins University
University of Alabama at Birmingham
Education Development Center, Inc.
Information provided by (Responsible Party):
Centre for Infectious Disease Research in Zambia

Brief Summary:
This study will evaluate two Train-the-Trainer implementation strategies to increase and better sustain the number of providers delivering evidence-based mental health services in low and middle-income countries (LIMC). The first strategy is the gold standard approach using experts to do a "live" training and the second is a technology based strategy. Evaluation will include trainer and provider competency, knowledge and fidelity, as well as cost effectiveness and will be relevant for diverse evidence-based practices that are not being scaled-up in LMIC.

Condition or disease Intervention/treatment Phase
Depression Post-traumatic Stress Disorder Anxiety Substance Abuse Other: Train the trainer Not Applicable

Detailed Description:
The overall objective of this study is to evaluate implementation strategies that can reduce the science-to-practice gap of evidence-based treatments (EBT) for mental health. Although evidence suggests that mental health treatments are acceptable and efficacious in low-and-middle income countries (LMIC) for the treatment of common mental disorders, there remains a gap in our understanding of how to bring these interventions to scale. A significant challenge is training and sustaining counselors in EBT. Implementation research will be performed to evaluate the effectiveness of two Train-the-Trainer (TTT) implementation strategies to increase and sustain the number of counselors in a non-inferiority design. One TTT strategy is the gold-standard of utilizing expert trainers to conduct in-person training and coaching to produce local trainers. The second strategy is technology based with no experts needed on-site, utilizing phones that function both on and offline and allow for pre-recorded teachings. Trainers (6-8) will be randomized to one of the TTT strategies, and subsequently complete two Common Elements Treatment Approach (CETA) trainings with local lay counselors. A total of 100 lay counselors trained in CETA will serve at least 5 adolescents or young adults under supervision of the local trainers. The transdiagnostic treatment being scaled up, CETA, was effective in two randomized clinical trials in LMIC settings with lay providers. CETA provides the basis for feasible scale-up through the use a single therapy to treat multiple common mental disorders with varying severities, an approach that is more cost-effective than implementing multiple single-disorder focused psychotherapy treatments in LMIC. Outcomes will include: 1) trainer and counselor competency, knowledge and fidelity through tests, behavioral rehearsal, and audio/video recordings, 2) client mental health symptomatology, and 3) implementation constructs of reach, acceptability, appropriateness, feasibility, and scale-up potential. The cost-effectiveness of the two TTT strategies will also be evaluated. The project will specifically strengthen the capacity of: 1) study staff to conduct mental health implementation science research, 2) counselor and trainers in CETA training, supervision and delivery, and 3) policy and decision makers to interpret and appropriately utilize the scientific evidence to improve mental health policies and programs. At 15+ organizations with CETA providers, monitoring systems will be set up to assess quality, reach and cost going beyond the study. These aims will contribute to developing dynamic sustainable Learning Health Care Systems in LMIC. This proposal leverages previous studies and strong collaborations in Zambia with the Ministry of Health and numerous local organizations. Results from this trial will produce effectiveness and costing data on 2 TTT strategies that could inform the scale-up potential of diverse EBT in LMIC across and beyond mental health. This research study ultimately addresses both the treatment and implementation gaps in lower-resource settings globally.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 608 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 8 counselors who are experienced delivering a cognitive behavioral therapy approach called Common Elements Transdiagnostic Approach (CETA) will be randomized 1:1 to either the Live or Technology train-the-trainer program. These trainers will then train 100 counselors in CETA. After being trained in CETA, the counselors will treat 500 patients with mental health and/or substance use problems.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Active Comparator: Live TTT
This is the standard of care train-the-trainer approach for experienced counselors
Other: Train the trainer
Training the trainer involves taking an experienced counselor and teaching them how to train additional counselors in a specific therapy. A technology-based train the trainer strategy will be developed and tested. The hypothesis is that the technology strategy will have similar effectiveness to the standard live strategy. Therefore, all experienced-counselors will receive a train-the-trainer intervention.

Experimental: Technology TTT
This is an experimental technology-based train-the-trainer approach for experienced counselors
Other: Train the trainer
Training the trainer involves taking an experienced counselor and teaching them how to train additional counselors in a specific therapy. A technology-based train the trainer strategy will be developed and tested. The hypothesis is that the technology strategy will have similar effectiveness to the standard live strategy. Therefore, all experienced-counselors will receive a train-the-trainer intervention.




Primary Outcome Measures :
  1. Change in competency & knowledge of Common Elements Treatment Approach (CETA) [ Time Frame: Change from baseline to 1 month after training ]
    Assess change in competency and knowledge of trainers and of counselors in provision of CETA

  2. Change in client symptoms [ Time Frame: Change from baseline to 9 months after first CETA session ]
    To monitor mental health symptom change a client monitoring form will be used. This will be assessed before each CETA session and allow evaluation of client outcomes.

  3. Cost effectiveness of Live and Tech train-the-trainer strategies [ Time Frame: At baseline during training ]
    The economic analysis will use bottom-up, ingredients-based cost models from both the societal and payers' perspective and will estimate the incremental cost per competent counselor via either Live or Tech approach.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of Zambian
  • Counselor who is experienced in delivery of Common Elements Treatment Approach to treat mental health and/or substance use issues

Exclusion Criteria:

  • Not planning to reside in Lusaka area long-term

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458039


Contacts
Contact: Izukanji Sikazwe, MBChB +260 977233829 izukanji.sikazwe@cidrz.org
Contact: Laura Murray, PhD +1 917-617-0234 lmurra15@jhu.edu

Sponsors and Collaborators
Centre for Infectious Disease Research in Zambia
Johns Hopkins University
University of Alabama at Birmingham
Education Development Center, Inc.
Investigators
Principal Investigator: Izukanji Sikazwe, MBChB Chief Executive Officer

Publications:

Responsible Party: Centre for Infectious Disease Research in Zambia
ClinicalTrials.gov Identifier: NCT03458039     History of Changes
Other Study ID Numbers: 1U01MH115495 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All necessary steps will be taken to ensure adherence to all NIH guidelines on sharing raw data.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Pending
Access Criteria: Pending
URL: http://www.cidrz.org

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre for Infectious Disease Research in Zambia:
mental health capacity building
low and middle-income country
train the trainer strategy
technology-based training

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders