NCT07453758

Brief Summary

The study takes place in Tajikistan, a postwar country in Central Asia, where Dr. Weine, Dr. Pirova, Dr. Bahromov, and other collaborators successfully implemented a D43 research capacity building project and an R21 and R01 on stepped care for women's mental health in primary care. This study also builds on the team's prior research that demonstrated the effectiveness of nurse- and peer-led interventions, identified risk and protective factors for suicide among women, and on the PREVAIL peer-led suicide prevention model. The specific aims for this new project are: Aim 1: Adapt the evidence-based PREVAIL model into a new SUSTAIN nurse- and peer-led suicide prevention model in primary care for women at moderate or high suicide risk in rural and urban Tajikistan using a participatory co-design process (the Transcreation Framework) with multi-level partners. Aim 2: Evaluate a pilot implementation of the SUSTAIN model in primary care among 96 women with moderate to high suicide risk, 48 randomized to SUSTAIN and 48 to an enhanced usual care condition, with both groups followed for 9 months for suicidal ideations or behaviors, mental health outcomes, and mediators. Aim 3: Assess the acceptability, feasibility, appropriateness, potential for scalability and sustainability, programmatic costs, and partnership of SUSTAIN to inform a future hybrid type 2 effectiveness-implementation pragmatic trial.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress42%
Jan 2026Feb 2027

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 3, 2026

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

February 27, 2026

Last Update Submit

May 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Columbia Suicide Severity Rating Scale

    Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) Any suicide attempt as measured according to an electronic self-report version of the Columbia Suicide Severity Rating Scale (CSSR-S). The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S.

    Baseline and 3, 6, 9 months post intervention

Secondary Outcomes (12)

  • Medically serious suicide attempts

    3, 6, and 9 months post intervention

  • Suicide Cognitions Scale-Short Form (SCS-S)

    3, 6, and 9 month post intervention

  • Beck Hopelessness Scale (BHS)

    3, 6, 9 months post intervention

  • Brief Reasons for Living (BRFL)

    3, 6, 9 month post intervention

  • Patient Health Questionnaire-9 (PHQ-9)

    3, 6, 9 month post intervention

  • +7 more secondary outcomes

Study Arms (2)

SUSTAIN intervention

EXPERIMENTAL

Women in the 6 intervention clinics will be enrolled in the SUSTAIN intervention. This includes nurse and peer co-lead individual, group and family sessions. There are 9 sessions that are attended by the women (6 individual and 3 group) and 1 session that is attended by their family members; this will occur over the course of 8-12 weeks depending on timing and scheduling. The SUSTAIN Model consists of: * Six individual sessions for women at-risk of suicide (once a week for 1-1.5 hours) * Three group sessions for women at-risk of suicide (once a week for 2 hours) * One education group session for families of women at-risk of suicide (note, the women do not attend this session)

Behavioral: Suicide prevention treatment

Enhanced Care as Usual

OTHER

In the 6 clinics assigned to the control condition, the women who screen positive for moderate to high suicide risk will receive enhanced usual care. They will be evaluated by a family medicine doctor who will confirm their level of risk and decide on appropriate actions. This could include an admission to inpatient psychiatry, a referral to outpatient psychiatry, or management in the family medicine clinic which may include counseling, psychiatric medication, a family meeting, or a home visit. At the very least, the family medicine doctor will provide them with a list of local crisis support resources.

Behavioral: Care as usual

Interventions

SUSTAIN intervention is a nurse and peer-led individual, group and family sessions suicide prevention intervention. There are 9 sessions that are attended by the women (6 individual and 3 group) and 1 session that is attended by their family members; this will occur over the course of 8-12 weeks depending on timing and scheduling.

SUSTAIN intervention
Care as usualBEHAVIORAL

Enhanced usual care (EUC) control condition): In the 6 clinics assigned to the control condition, the women who screen positive for moderate to high suicide risk will receive enhanced usual care. They will be evaluated by a family medicine doctor who will confirm their level of risk and decide on appropriate actions. This could include an admission to inpatient psychiatry, a referral to outpatient psychiatry, or management in the family medicine clinic which may include counseling, psychiatric medication, a family meeting, or a home visit. At the very least, the family medicine doctor will provide them with a list of local crisis support resources.

Enhanced Care as Usual

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Tajik women age 18 to 59 who meet operationally defined criteria for moderate or high risk suicide risk. We will identify women at-risk for suicide defined as:
  • a recent suicide attempt (past 3 months)
  • recent suicidal ideation that is accompanied by either a plan or intention as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). If they score a level 2 or higher on the C-SSRS, they are eligible. Level 2 refers to non-specific active suicidal thoughts. At level 2, a person has general, active thoughts of wanting to end their life but has not formulated a specific plan, method, or intention to act on them.

You may not qualify if:

  • If they score less than a level 2 on the C-SSRS they are not eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRISMA research center

Dushanbe, Tajikistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 6, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

June 3, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations