Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 4:13 AM
Study NCT ID:
NCT07453758
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nurse and Peer Led Suicide Prevention in Tajikistan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Columbia Suicide Severity Rating Scale', 'timeFrame': 'Baseline and 3, 6, 9 months post intervention', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Medically serious suicide attempts', 'timeFrame': '3, 6, and 9 months post intervention', 'description': "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."}, {'measure': 'Suicide Cognitions Scale-Short Form (SCS-S)', 'timeFrame': '3, 6, and 9 month post intervention', 'description': 'A tool designed to measure intense feelings of hopelessness, unlovability, and inability to cope, often associated with chronic suicide risk.\n\nB-SCS employs Likert-scaling (1-5) and scores are calculated by summing the keyed responses and yields a score between 6 and 30'}, {'measure': 'Beck Hopelessness Scale (BHS)', 'timeFrame': '3, 6, 9 months post intervention', 'description': "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."}, {'measure': 'Brief Reasons for Living (BRFL)', 'timeFrame': '3, 6, 9 month post intervention', 'description': '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.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '3, 6, 9 month post intervention', 'description': '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).'}, {'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '3, 6, 9 months post intervention', 'description': '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'}, {'measure': 'PTSD CheckList - Civilian Version (PCL-C)', 'timeFrame': '3, 6, 9 months post intervention', 'description': '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.'}, {'measure': 'Abuse Assessment Screen', 'timeFrame': '3, 6, 9 month post intervention', 'description': '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.'}, {'measure': 'Pearlin Mastery Scale', 'timeFrame': '3, 6, 9 months post intervention', 'description': "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."}, {'measure': 'Mental Health Knowledge Schedule (MAKS)', 'timeFrame': '3, 6, 9 months post intervention', 'description': '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).'}, {'measure': 'Short Form Health Survey (SF-12)', 'timeFrame': '3, 6, 9 months post intervention', 'description': "The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life.\n\nThe 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."}, {'measure': 'Interpersonal Needs Questionnaire (INQ)', 'timeFrame': '3, 6, 9 months post intervention', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide Ideation']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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:\n\n 1. a recent suicide attempt (past 3 months)\n 2. 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.\n\nOther inclusion criteria are: 1) willing to participate in the SUSTAIN intervention and research procedures; and 2) able to give written informed consent.\n\nExclusion Criteria:\n\n* If they score less than a level 2 on the C-SSRS they are not eligible'}, 'identificationModule': {'nctId': 'NCT07453758', 'briefTitle': 'Nurse and Peer Led Suicide Prevention in Tajikistan', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Nurse and Peer Led Suicide Prevention in Tajikistan', 'orgStudyIdInfo': {'id': '2025-0021'}, 'secondaryIdInfos': [{'id': 'R34MH136247', 'link': 'https://reporter.nih.gov/quickSearch/R34MH136247', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUSTAIN intervention', 'description': '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.\n\nThe SUSTAIN Model consists of:\n\n* Six individual sessions for women at-risk of suicide (once a week for 1-1.5 hours)\n* Three group sessions for women at-risk of suicide (once a week for 2 hours)\n* One education group session for families of women at-risk of suicide (note, the women do not attend this session)', 'interventionNames': ['Behavioral: Suicide prevention treatment']}, {'type': 'OTHER', 'label': 'Enhanced Care as Usual', 'description': '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.', 'interventionNames': ['Behavioral: Care as usual']}], 'interventions': [{'name': 'Suicide prevention treatment', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['SUSTAIN intervention']}, {'name': 'Care as usual', 'type': 'BEHAVIORAL', 'description': 'Enhanced usual care (EUC) control condition):\n\nIn 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.', 'armGroupLabels': ['Enhanced Care as Usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dushanbe', 'country': 'Tajikistan', 'contacts': [{'name': 'Jonbek Jonbekov', 'role': 'CONTACT', 'email': 'jonbek@mail.ru', 'phone': '+992 93 843 2398'}], 'facility': 'PRISMA research center', 'geoPoint': {'lat': 38.53575, 'lon': 68.77905}}], 'centralContacts': [{'name': 'Stevan Weine, MD', 'role': 'CONTACT', 'email': 'smweine@uic.edu', 'phone': '(312) 355-5407'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}