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

Centre for Infectious Disease Research in Zambia

Status: Completed

Conditions: Post-traumatic Stress Disorder; Depression; Substance Abuse; Anxiety

Treatments: Behavioral: Telephone CETA; Behavioral: Treatment as Usual (TAU); Behavioral: In-person CETA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03458039

R01MH115495

Details and patient eligibility

About

This study utilizes a Hybrid Type 1 multi-arm parallel group randomized control design to compare the effectiveness of an evidence-based treatment (CETA) delivered either in-person or via telephone, compared with a treatment as usual (TAU) control group, on improving adolescent and young adult (AYA) mental and behavioral health outcomes. The study will also gather information on counselor treatment knowledge, fidelity and competency following a technology-delivered training. Lastly, the cost associated with these strategies will be explored to inform future scale-up of training and services. This study will be conducted in Lusaka, Zambia and participants will be enrolled at four different levels: prospective CETA trainers, prospective CETA counselors, AYA clients, and research/organizational staff. AYA clients are the primary participant type.

Full description

The overall objective of this study is to evaluate implementation and service delivery 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. Significant challenges include the high cost of in-person training, sustaining counselors in EBT, and limited client access to effective care.

The aim of this study is to test whether delivery of telephone CETA (T-CETA) can produce non-inferior, or similar, results to the standard in-person CETA for reducing mental and behavioral health problems among AYA and whether CETA and T-CETA are superior to treatment as usual (TAU) in reducing these problems. The study design is a randomized, non-inferiority trial. CETA trainers (up to n=6) will be identified from an existing cadre of Zambian trainers-in-training (TTT), who will facilitate technology-delivered trainings for prospective counselors (up to n = 50) from several partner organizations in Zambia. Counselors who participate in the training will be trained in both in-person CETA and T-CETA. Once trained, counselors will provide treatment to AYA clients randomized to the CETA or T-CETA condition. Following completion of the study, TAU control participants will be offered CETA.

The transdiagnostic treatment being scaled up, CETA, was effective in several previous randomized clinical trials in LMIC settings with lay providers, including in Zambia. 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.

Primary outcomes will be AYA client mental health and behavioral health outcomes. Secondary outcomes include trainer and counselor CETA competency and knowledge, and qualitative interviews of the acceptability, appropriateness, feasibility, and scale-up potential of technology-based CETA training and treatment delivery. The cost-effectiveness of the technology training strategy and the two treatment delivery methods will also be evaluated.

The project will specifically strengthen the capacity of: 1) study staff to conduct mental health clinical 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. 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 treatment delivery 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.

Enrollment: 456 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

CETA Counselors

Inclusion:

1. 18 years of age or older
2. Interest in providing CETA
3. Time/availability to participate in the study
4. Minimal education level is comparable to a high school education
5. Ability to speak English fluently and speak at least 1 local language (Nyanja or Bemba)
6. Completion of an in-person interview with study team investigators demonstrating strong communication skills
7. Planning to stay in study area (Lusaka) to provide treatment to clients

Exclusion:

1. If previously trained in CETA

CETA Trainers

Inclusion:

1. All eligibility criteria for CETA counselors
2. Interest in teaching CETA
3. Completion of the CETA training
4. Completion of a minimum of 3 CETA cases under supervision

Adolescent/Young Adult (AYA) Clients

Inclusion:

1. 15-29 years of age

2. Attend or be referred to study site

3. Live in the area served by a study site (i.e., not staying temporarily)

4. Ability to speak one of the study languages (English, Bemba, or Nyanja)

5. Screening: Present with one or more common mental/behavioral health problems based on validated screening tools included in the audio computer assisted self-interviewing (ACASI) system. Specifically, the following screening tools and cut-off values:

   1. Youth Self Report Internalizing Scale (≥14)
   2. Youth Self Report Externalizing Scale (≥8)
   3. Child PTSD Symptom Scale (≥11.5)

Exclusion:

1. Currently on unstable psychiatric drug regimen (e.g., altered in past two months)
2. Suicide attempt or active and severe self-harm in past month
3. Psychotic disorder or severe mental illness

Research/Organizational Staff

Inclusion:

1. Involved in development and/or implementation of the technology training platform, including clinical, research, and web development staff.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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456 participants in 3 patient groups

In-person CETA

Experimental group

Description:

This is the in-person delivery method of the Common Elements Treatment Approach (CETA).

Treatment:

Behavioral: In-person CETA

Telephone CETA (T-CETA)

Experimental group

Description:

This is the technology-based delivery method for the Common Elements Treatment Approach (CETA).

Treatment:

Behavioral: Telephone CETA

Treatment As Usual

Active Comparator group

Description:

This is the treatment as usual control condition who will engage with their usual care in the community and will receive CETA, if desired, following completion of the study.

Treatment:

Behavioral: Treatment as Usual (TAU)