Clinical trial NCT04110405: Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC
Official title: Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Prisma Research Center
name: University of Utah
name: New York University
First posted: 2019-10-01
Enrollment: 630
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines: 1) short-term and longitudinal impacts of stepped care on women with depression and the possible roles of mediators and moderators; 2) clinic- (readiness to adopt an innovation, leadership support and climate) and provider-level (preparedness, motivation and fidelity) factors that may affect stepped care implementation; and 3) the differential impact of two implementation approaches (a clinic implementation teams versus implementation training by the research team). It utilizes Curran's hybrid effectiveness implementation design, mixed methods, and a longitudinal design with assessments at pre, 3 months, 6 months, and 12 months. A total of 18 primary care clinics, set in both rural and urban communities in Tajikistan, will be involved, with 12 delivering the intervention and 6 acting as controls. 8 providers (3 nurses, 3 peers, and 2 doctors) will be recruited at each of the 12 intervention clinics for a total of 96 providers; 35 women with depression will be recruited from each clinic for a total of 630 women.

Detailed description: This research will advance mental healthcare task sharing in effectiveness and implementation testing of a stepped care model for LMICs. It uses nurses and mental health peers to treat depression and potential co-occurring anxiety among women in primary care. The study addresses Grand Challenges in Global Mental Health Goal C to foster integration of mental health into primary care and NIMH Strategic Aim 3 by developing new and better interventions that incorporate the diverse needs and circumstances of people with mental illness. It utilizes Curran's hybrid effectiveness implementation design. To improve implementation, it examines the impact of clinic implementation teams in readying the clinic and service providers. Additionally, it explores how RDoC neuroscience contributes to implementation science through enhancing the evaluation and targeting of stepped care. This study will enable new collaborative research activities, in tandem with network building, mentorship and training, and dissemination of findings, which will further build the LMIC capacity for implementation science research and development of evidence-based medicine by strengthening Tajikistan's individual and institutional research capabilities.

Globally, young women bear a disproportionate burden of common mental disorders, and especially including depression and potentially co-occurring anxiety. With current care models, this burden cannot be lifted without finding ways to deliver mental health prevention and treatment services and illness self-management to women in primary care. Our previous research in Tajikistan has demonstrated that women are exposed to serious risks for mental illness, and how peers and primary care nurses have played major but largely informal roles in helping women with mental health problems. Therefore, the investigators developed and tested for feasibility a stepped care model which showed very strong treatment effects. This stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline.

This project will scale-up the intervention in multiple polyclinics, so as to examine its effectiveness (Aim 2) and to compare two implementation strategies (Aim 3). This presents a remarkable opportunity to advance both services and science of mental health in Tajikistan.

Aim 1. To assess the effectiveness of the stepped care model with 420 women who have depression and potential co-occurring anxiety, recruited from 12 primary care clinics in Tajikistan, compared with standard of care plus provision of healthy lifestyle materials, with another 210 women recruited from 6 primary care clinics, including assessing mediators and moderators (e.g. executive control efficiency, trauma exposure).

Aim 2. To assess whether a clinic implementation team moderates women's reduction in depression post-intervention, as well as clinic-level (leadership support and degree of implementation) and provider-level (motivation and fidelity) moderators.

Aim 3. To establish a national mental health research network that focuses on improving the standard of mental health care and access to services by building mental health implementation research capacity.

Eligibility criteria: Inclusion Criteria:

* female Tajik citizen between 18 and 45 years old
* score \>16 on the HAM-D
* no current or past substance use
* willing to participate in the intervention and research procedures
* able to give written informed consent.

Exclusion Criteria:

* women who are older or younger than 18 - 45 years
* women who do not score \>16 on the HAM-D

Primary outcomes:
measure: change in Hamilton Depression Rating Scale
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: change in Texas Christian University (TCU) Organizational Readiness for Change
timeFrame: baseline, 3 months, 6 months, and 12 months
Secondary outcomes:
measure: change in Hamilton Anxiety Rating Scale
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: change in PTSD Checklist for DSM- 5
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: change in Evidence Based Practice Attitude Scale
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: # Stepped Care interventions initiated and completed
timeFrame: baseline, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Dushanbe
country: Tajikistan
facility: City Health Center #4
city: Dushanbe
country: Tajikistan
facility: City Health Center #5
city: Dushanbe
country: Tajikistan
facility: Dushanbe City Health Center #12
city: Dushanbe
country: Tajikistan
facility: Dushanbe City Health Center #13
city: Dushanbe
country: Tajikistan
facility: Dushanbe City Health Center #15
city: Dushanbe
country: Tajikistan
facility: Dushanbe City Health Center #1
city: Dushanbe
country: Tajikistan
facility: Dushanbe City Health Center #2
city: Dushanbe
country: Tajikistan
facility: Dushanbe City Health Center #6
city: Guliston
country: Tajikistan
facility: Guliston District Health Center
city: Khujand
country: Tajikistan
facility: Gafurov District Health Center
city: Khujand
country: Tajikistan
facility: Kayrokum District Health Center #7
city: Khujand
country: Tajikistan
facility: Khujand City Health Center #1
city: Khujand
country: Tajikistan
facility: Khujand City Health Center #2
city: Khujand
country: Tajikistan
facility: Khujand City Health Center #3
city: Khujand
country: Tajikistan
facility: Khujand City Health Center #4
city: Khujand
country: Tajikistan
facility: Khujand City Health Center #5
city: Khujand
country: Tajikistan
facility: Khujand City Health Center #6
city: Rudaki
country: Tajikistan
facility: Rudaki District Health Center
city: Shahrinav
country: Tajikistan
facility: Shahrinav District Health Center
city: Varzob
country: Tajikistan
facility: Varzob District Health Center
Study officials:
References: