Scaling-Up Stepped Care for Women's Mental Health in Primary Care in an LMIC
1 other identifier
interventional
630
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Aug 2020
Longer than P75 for not_applicable depression
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedStudy Start
First participant enrolled
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedJune 27, 2023
June 1, 2023
2.6 years
September 18, 2019
June 26, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
change in Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HAM-D) is a way of determining a patient's level of depression before, during, and after treatment. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Score of 0-7 = normal; 8-13 = mild depression; 14-18 = moderate depression; 19-22 = severe depression, +23 = very severe depression.
baseline, 3 months, 6 months, and 12 months
change in Texas Christian University (TCU) Organizational Readiness for Change
Motivational factors include program needs, training needs, and pressures for change, while program resources are evaluated in regard to office facilities, staffing, training, equipment, and the Internet. Organizational dynamics include scales on staff attributes and climate. Numbers for each item indicate its location in the administration version, in which response categories are 1=Strongly Disagree to 5=Strongly Agree; ® designates items with reflected scoring. Scores for each scale are obtained by summing responses to its set of items (after reversing scores on reflected items by subtracting the item response from "6"), dividing the sum by number of items included (yielding an average) and multiplying by 10 in order to rescale final scores so they range from 10 to 50 (e.g., an average response of 2.6 for a scale becomes a score of "26").
baseline, 3 months, 6 months, and 12 months
Secondary Outcomes (4)
change in Hamilton Anxiety Rating Scale
baseline, 3 months, 6 months, and 12 months
change in PTSD Checklist for DSM- 5
baseline, 3 months, 6 months, and 12 months
change in Evidence Based Practice Attitude Scale
baseline, 3 months, 6 months, and 12 months
# Stepped Care interventions initiated and completed
baseline, 3 months, 6 months, and 12 months
Study Arms (2)
Stepped Care
EXPERIMENTALTo 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.
Standard of Care plus Healthy Lifestyle
ACTIVE COMPARATORTo compare standard of care plus healthy lifestyle materials with 210 women recruited from 6 primary care clinics in Tajikistan.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- women who are older or younger than 18 - 45 years
- women who do not score \>16 on the HAM-D
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- Prisma Research Centercollaborator
- University of Utahcollaborator
- New York Universitycollaborator
Study Sites (20)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
September 18, 2019
First Posted
October 1, 2019
Study Start
August 14, 2020
Primary Completion
April 1, 2023
Study Completion
October 1, 2024
Last Updated
June 27, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share