Clinical trial NCT03458039: Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia
Official title: Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Post-traumatic Stress Disorder
Anxiety
Substance Abuse
Keywords: mental health capacity building
low and middle-income country
train the trainer strategy
technology-based training
implementation science
adolescents and young adults (AYA)
Lead sponsor: Centre for Infectious Disease Research in Zambia
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Alabama at Birmingham
name: Education Development Center, Inc.
name: Columbia University
First posted: 2018-03-08
Enrollment: 456
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents and young adults (AYA) with indicated mental health or behavioral health problems will be randomized to either the in-person CETA (n = 150), T-CETA (n=150), or treatment as usual condition (n = 100), for a total of 400 AYA participants. Each counselor will be trained in both CETA and T-CETA delivery methods.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in adolescent and young adult (AYA) internalizing and externalizing symptoms as measured by the Youth Self Report
timeFrame: Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).
measure: Change in adolescent and young adult (AYA) trauma symptoms as measured by the Child PTSD Symptom Scale
timeFrame: Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).
Secondary outcomes:
measure: Change in adolescent and young adult (AYA) substance use as measured by the ASSIST
timeFrame: Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).
measure: Change in adolescent and young adult (AYA) physical health and functioning as measured by the EQ-5D-Y
timeFrame: Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).
measure: Trainer competency & knowledge of Common Elements Treatment Approach (CETA).
timeFrame: Outcomes at the trainer level will be assessed at three time points: 1) after CETA counselor training (baseline), 2) three months into active cases (3 months post-baseline), and 3) at posttreatment (~9 months post-baseline).
measure: Counselor competency & knowledge of Common Elements Treatment Approach (CETA).
timeFrame: Outcomes at the counselor level will be assessed at three time points: 1) after baseline CETA counselor training, 2) three months into active cases (3 months from baseline), and 3) following provision of CETA treatment (~9 months post-baseline).
measure: Cost effectiveness of adapting training for technology delivery, and in-person and telephone delivery of CETA.
timeFrame: Costs assessed throughout course of the study up to 48 months.
measure: Challenges, advantages, feasibility, acceptability, and sustainability of a technology-delivered training and supervision model.
timeFrame: Trainer and counselor qualitative interviews will be conducted at two time points: 1) After counselor training (baseline), and 2) At post-treatment of CETA cases (~9 months post-baseline).
measure: Challenges, advantages, feasibility, acceptability, and sustainability of a telephone-delivered treatment delivery model (T-CETA).
timeFrame: AYA qualitative interviews will be conducted at CETA posttreatment (~3 months post-baseline).
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Centre for Infectious Disease Research in Zambia
Study officials:
affiliation: Chief Executive Officer
name: Izukanji Sikazwe, MBChB
role: PRINCIPAL_INVESTIGATOR
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