Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC

NCT ID: NCT04110405

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 630 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2024-10-01

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stepped Care

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.

Group Type: EXPERIMENTAL

Stepped Care

Intervention Type: BEHAVIORAL

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.

Standard of Care plus Healthy Lifestyle

To compare standard of care plus healthy lifestyle materials with 210 women recruited from 6 primary care clinics in Tajikistan.

Group Type: ACTIVE_COMPARATOR

Standard of Care plus Healthy Lifestyle

Intervention Type: BEHAVIORAL

Standard outpatient care supplemented with literature on healthy lifestyles will serve as an enhanced control condition. In each clinic, non-specialty mental health care is available in the form of counseling from doctors or nurses along with psychiatric medication management. Given the difficulties faced by women in Tajikistan, ethical responsibility compels us to enhance the control condition by having nurses distribute written materials on healthy eating, physical fitness, and personal hygiene, at a reading level which will be widely accessible.

Interventions

Stepped Care

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.

Intervention Type: BEHAVIORAL

Standard of Care plus Healthy Lifestyle

Standard outpatient care supplemented with literature on healthy lifestyles will serve as an enhanced control condition. In each clinic, non-specialty mental health care is available in the form of counseling from doctors or nurses along with psychiatric medication management. Given the difficulties faced by women in Tajikistan, ethical responsibility compels us to enhance the control condition by having nurses distribute written materials on healthy eating, physical fitness, and personal hygiene, at a reading level which will be widely accessible.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prisma Research Center

UNKNOWN

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: collaborator

New York University

OTHER

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Stevan Weine

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

City Health Center #4

Dushanbe, , Tajikistan

City Health Center #5

Dushanbe, , Tajikistan

Dushanbe City Health Center #12

Dushanbe, , Tajikistan

Dushanbe City Health Center #13

Dushanbe, , Tajikistan

Dushanbe City Health Center #15

Dushanbe, , Tajikistan

Dushanbe City Health Center #1

Dushanbe, , Tajikistan

Dushanbe City Health Center #2

Dushanbe, , Tajikistan

Dushanbe City Health Center #6

Dushanbe, , Tajikistan

Guliston District Health Center

Guliston, , Tajikistan

Gafurov District Health Center

Khujand, , Tajikistan

Kayrokum District Health Center #7

Khujand, , Tajikistan

Khujand City Health Center #1

Khujand, , Tajikistan

Khujand City Health Center #2

Khujand, , Tajikistan

Khujand City Health Center #3

Khujand, , Tajikistan

Khujand City Health Center #4

Khujand, , Tajikistan

Khujand City Health Center #5

Khujand, , Tajikistan

Khujand City Health Center #6

Khujand, , Tajikistan

Rudaki District Health Center

Rŭdakí, , Tajikistan

Shahrinav District Health Center

Shahrinav, , Tajikistan

Varzob District Health Center

Varzob, , Tajikistan

Countries

Tajikistan

Other Identifiers

2019-0745

Identifier Type: -

Identifier Source: org_study_id