Suicide Clinical Trial
— KPZOfficial title:
Opportunities for Suicide Prevention Integration Into Task-shifted Mental Health Interventions in Low-resourced Contexts
Investigators will conduct a pilot clinical trial to assess the feasibility and acceptability of implementing a Suicide Prevention Package (SuPP) within an existing task-shifted depression intervention in rural Pakistan. This pilot research lays the groundwork for a future project to scale a package for multi-level suicide prevention strategies that can be integrated into community based mental health programs, particularly targeting individuals living in low-resourced settings. As the model is designed to be easily adapted and integrated, investigators anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | July 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for trial participants receiving the intervention: - Speak Urdu fluently - Be actively receiving care from a clinician - Have access to a mobile phone - Intending to reside in the study area for the entire duration of the follow up (approx. six months) - Has a child 3 years or under or is pregnant Exclusion Criteria for trial participants receiving the intervention: - Women requiring immediate inpatient care for any reason (medical or psychiatric) - Women who do not speak and/or comprehend Urdu language Inclusion Criteria for Peers and health system stakeholders: - Speak Urdu fluently - Be older than 18 at the time of recruitment - Have access to a mobile phone - Intending to reside in the study area for the entire duration of the follow up (approx. six months) Exclusion Criteria for Peers and health system stakeholders: - Women with untreated suicidality - Women who do not speak and/or comprehend Urdu language |
Country | Name | City | State |
---|---|---|---|
Pakistan | Islamabad Capital Territory | Islamabad |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Mental Health (NIMH) |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean score Beck's Scale for Suicidal Ideation (BSI) | Suicide ideation severity measured with BSI. BSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and plans to commit suicide during the past week. The first 19 items consist of three options graded are on a 3-point scale ranging from 0 to 2. These items are then summed to yield a total score, which ranges from 0 to 38. Higher scores indicate more higher severity of suicide ideation. | baseline, 3 months and 6 months | |
Primary | Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS) | Suicidal behaviors and attempts measured with the CSSRS. The CSSRS asks about self-reported suicide attempt, aborted attempt, and interrupted attempt with "yes" or "no" questions. Any positive responses to these behaviors will be qualitatively coded as 'yes'. Behaviors are assessed at baseline as the past month and at 3 months and 6 months from the time of the previous assessment (e.g., past 3 months). | baseline, 3 months and 6 months | |
Primary | Percent eligible participants who consent | Percent eligible participants who agreed to participate | 6 months | |
Primary | Percent of consented participants who started intervention | Percent consented participants who started intervention | 6 months | |
Primary | Percent of participants who completed KPZ safety card | Percent of participants enrolled who completed KPZ safety card | 6 months | |
Primary | Percent of participants who completed one brief contact follow up session | Percent of participants who completed one brief contact follow up session | 6 months | |
Primary | Percent of participants who dropped out of KPZ intervention | Percent of participants who dropped out of KPZ intervention | 3 months and 6 months | |
Primary | Median number of sessions completed | Median number of sessions completed by participants | 6 months | |
Primary | Percent participants who completed all follow up measures | Percent participants who completed all follow up measures | 6 months | |
Primary | Percent missing measure items per participant | Percent of missing measure items per participant | 6 months | |
Secondary | Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM). | All 3 scales are 4-items to assess core implementation outcomes of implementer perceptions of the KPZ intervention. FIM assesses if the intervention is feasible, possible, and easy, AIM assesses the implementation outcome of acceptability where respondents indicate their approval, find it appealing, express liking, and welcome the intervention strategy, providing valuable insights into the overall acceptability of the implemented approach. IAM measures appropriateness as an implementation outcome measuring if the intervention seems fitting, seems suitable, seems applicable, and seems like a good match. Responses for all scales use a 5-point ordinal likert scale, ranging from 1=completely disagree to 5=completely agree. | 6 months | |
Secondary | Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention | The KAC is a 30-item questionnaire developed from our formative co-design research that assesses implementing agent (e.g., Peer) implementation domains of confidence (11 items), attitudes (acceptability, appropriateness, perceived benefit) (13 items), and knowledge (6 items) in implementing the elements of KPZ with the mother directly and within her social milieu (e.g., family engagement). The questionnaire assesses implementer understanding of their roles, confidence in identifying mothers at risk for suicide, and attitudes toward discussing and addressing suicide. Items are responded to with a 4-item Likert scale with responses ranging from 'none of the time' to 'all of the time'. The scale will be summed per sub-domain with a range of 0-39 for attitudes, 0-33 for confidence, and 0-18 for knowledge. Higher scores indicate more confidence, more positive attitudes, and more knowledge of KPZ intervention components and suicide myths. | 6 months | |
Secondary | Mean score Patient Health Questionnaire - 9 item (PHQ-9) | Depression measured with PHQ-9. PHQ-9 is a 9-item validated questionnaire. Each item asks about the frequency of specific depressive symptoms experienced over the past two weeks. The response options are scored from 0 to 3, indicating "not at all" to "nearly every day." The item scores are summed with total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms. | baseline, 3 months and 6 months | |
Secondary | Mean score Generalized Anxiety Disorder - 7 item (GAD-7) | Anxiety measured with GAD-7, a 7 item self report instrument that measures anxiety Items are scored on a 4-point scale, ranging from "not at all (0)" to "nearly everyday (3)". Item scores are summed with a total score ranging from 0 to 21: 0-4 Minimal anxiety; 5-9 Mild anxiety; 10-14 Moderate anxiety; 15-21 Severe anxiety. | baseline, 3 months and 6 months | |
Secondary | Mean score Multidimensional Scale of Perceived Social Support (MSPSS) | The MSPSS is a 12 item questionnaire intended to measure the extent to which an individual perceives social support from Significant Others, Family and Friends. Each item is scored from 1 = Very Strongly Disagree, to 7 = very strongly agree). Total Scale: Sum across all 12 items, then divide by 12. Total score range from 1 to 7. Higher scores indicate more perceived social support. | baseline, 3 months and 6 months | |
Secondary | Mean score Maternal Suicide Cognitions Scale | Maternal Suicide Cognitions Scale (developed from formative interviews with 20 women with a history of suicidal behavior or clinical practice with suicidal women and 3 focus group discussions with Pakistani clinicians to identify inductively defined mechanisms of suicidality) includes presence of the following characteristics hypothesized to be on the pathway to suicidality including : loneliness, abandonment, helplessness, hopelessness, burdensomeness, anger, patience and other concepts rated on a 3-point likert scale. Item scores are summed. Scores range from 16 to 48 with higher scores indicated more risk cognitions. | baseline, 3 months and 6 months | |
Secondary | Qualitative Interviews | Qualitative Interviews with trial participants, implementing agents (e.g., Peers and their supervisors), and health system stakeholders will elicit feasibility, acceptability, and perceived mechanisms of change. They will also inquire about adaptations (what, when, where, etc), familial, social and political factors that impacted KPZ implementation and engagement, and recommendations for changes for the future implementation. | 6 months |
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