- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07453758
Nurse and Peer Led Suicide Prevention in Tajikistan
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dushanbe, Tajikistan
- PRISMA research center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Other inclusion criteria are: 1) willing to participate in the SUSTAIN intervention and research procedures; and 2) able to give written informed consent.
Exclusion Criteria:
- If they score less than a level 2 on the C-SSRS they are not eligible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: SUSTAIN intervention
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:
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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.
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Other: Enhanced Care as Usual
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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Columbia Suicide Severity Rating Scale
Time Frame: Baseline and 3, 6, 9 months post intervention
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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.
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Baseline and 3, 6, 9 months post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Medically serious suicide attempts
Time Frame: 3, 6, and 9 months post intervention
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Medical record data on suicide attempts will be collected when a participant reports receiving care at an Emergency Room or hospital for reasons related on mental health or substance abuse on the Heath Services Inventory (HIS) at the 3, 6, and 9 month outcome assessments, or when a participant reports seeking medical attention for suicidal behavior during the Columbia Suicide Severity Rating Scale at the 3, 6, and 9 month outcome assessments.
Whenever a participant reports received medical attention on these measures, study staff will ask the participant to provide the name of the treating facility.
Before the follow-up visit is completed, the participant will be asked to sign a Request for Outside Records, allowing study staff to request medical records from any facility outside of study performance sites.
Signing this form is voluntary.
If a participant chooses not to sign a form, the participant's self-report will be used to measure medically serious suicide attempts.
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3, 6, and 9 months post intervention
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Suicide Cognitions Scale-Short Form (SCS-S)
Time Frame: 3, 6, and 9 month post intervention
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A tool designed to measure intense feelings of hopelessness, unlovability, and inability to cope, often associated with chronic suicide risk. B-SCS employs Likert-scaling (1-5) and scores are calculated by summing the keyed responses and yields a score between 6 and 30 |
3, 6, and 9 month post intervention
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Beck Hopelessness Scale (BHS)
Time Frame: 3, 6, 9 months post intervention
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The Beck Hopelessness Scale (BHS) is a 20-item, true/false self-report inventory designed to measure an individual's negative expectations and pessimism about the future, with higher scores indicating greater hopelessness.
It assesses feelings about the future, loss of motivation, and future expectations, with total scores ranging from 0-20.
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3, 6, 9 months post intervention
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Brief Reasons for Living (BRFL)
Time Frame: 3, 6, 9 month post intervention
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The BRFL is a 12-item self-report measure intended to assess adaptive beliefs and expectations for living.
The inventory has six subscales: fear of suicide, responsibility to family, survival and coping beliefs, child-related concerns, moral objections, and fear of social disapproval.
The 12 items are scored on a 6-point scale ranging from (1) "not at all important" to (6) "extremely important".
Higher scores on the BRFL scale and on its subscales reflect more reasons for living.
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3, 6, 9 month post intervention
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Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 3, 6, 9 month post intervention
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The PHQ-9 is a 9-question, self-report tool used to screen, diagnose, and monitor depression severity by measuring symptom frequency over the past two weeks.
It uses a 4-point Likert scale (0-3), with total scores ranging from 0 to 27.
Higher scores indicate greater severity (5-9: Mild, 10-14: Moderate, 15-19: Moderately severe, 20-27: Severe).
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3, 6, 9 month post intervention
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Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 3, 6, 9 months post intervention
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The Generalized Anxiety Disorder-7 (GAD-7) is a validated, 7-item self-report questionnaire designed to screen for and measure the severity of generalized anxiety disorder in the past two weeks.
Items are scored 0-3, totaling 0-21, with higher scores indicating greater anxiety severity.
Scores greater than 10 typically indicate a likely anxiety disorder
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3, 6, 9 months post intervention
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PTSD CheckList - Civilian Version (PCL-C)
Time Frame: 3, 6, 9 months post intervention
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The PCL-C is a 17-item self-report scale based on DSM-IV criteria for PTSD, designed to assess symptom severity over the past month in civilians without linking symptoms to a specific event.
It uses a 5-point Likert scale (1-5) for each item, with total scores ranging from 17 to 85. Scores above 44 indicate possible PTSD.
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3, 6, 9 months post intervention
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Abuse Assessment Screen
Time Frame: 3, 6, 9 month post intervention
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Abuse Assessment Screen (A.A.S.) is as a clinician-administered sexual and physical violence assessment tool for use in medical practice.
A.A.S. includes five questions about the experience of abusive behavior.
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3, 6, 9 month post intervention
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Pearlin Mastery Scale
Time Frame: 3, 6, 9 months post intervention
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The Pearlin Mastery Scale is a 7-item survey assessing an individual's sense of control over life circumstances, measuring a key psychological coping resource.
It uses a 4-point Likert scale (1=Strongly Disagree to 4=Strongly Agree), with total scores ranging from 7 to 28; higher scores indicate greater mastery.
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3, 6, 9 months post intervention
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Mental Health Knowledge Schedule (MAKS)
Time Frame: 3, 6, 9 months post intervention
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MAKS has been developed to measure mental health-related knowledge.
The tool assesses and tracks stigma-related mental health knowledge among the general public.
The Mental Health Knowledge Schedule (MAKS) uses a 5-point Likert scale to measure stigma-related knowledge (items 1-6) and illness recognition (items 7-12).
Only the first 6 items are scored for knowledge, ranging from 6 to 30, with higher scores indicating greater knowledge.
"Don't know" is generally scored as neutral (3).
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3, 6, 9 months post intervention
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Short Form Health Survey (SF-12)
Time Frame: 3, 6, 9 months post intervention
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The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12 health survey is scored by transforming responses into two main components: the Physical Component Summary (PCS) and Mental Component Summary (MCS). Using norm-based scoring, the average score for each component is 50, with a standard deviation of 10. Higher scores indicate better health-related quality of life, while scores below 50 suggest lower, below-average health. |
3, 6, 9 months post intervention
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Interpersonal Needs Questionnaire (INQ)
Time Frame: 3, 6, 9 months post intervention
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The INQ measures beliefs about the extent to which individuals believe their need to belong is met or unmet, as well as the extent to which they perceive themselves to be a burden on the people in their lives.
It uses a 7-point Likert scale (1 = "not at all true for me" to 7 = "very true for me") to rate items, with higher total scores indicating higher risk.
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3, 6, 9 months post intervention
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-0021
- R34MH136247 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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