SuicideKPZNCT06208293
Suicide Prevention Integration Into Task-shifted Mental Health Interventions
A study testing KPZ Program (KPZ) in people with Suicide and Suicide Prevention, run by Yale University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Suicide, Suicide Prevention, Suicidal Ideation
- What is being tested?
- KPZ Program (KPZ)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2024to 25 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Women with untreated suicidality
- Women who do not speak and/or comprehend Urdu language
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Read the detailed description
The proposed research will (1) examine the epidemiology and health impacts of recurrent suicidal ideation on mothers over time, (2) characterize key features of suicidal ideation and finalize intervention package components within the study context, and (3) 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, we anticipate the findings will be valuable for all researchers looking to improve population health and mental health services in disadvantaged settings. The focus of this registration is the pilot clinical trial.
A stratified cluster randomized controlled trial design, with 6 village clusters allocated in a 1:1 ratio to the intervention and control arms will be used. The stratification will be level of the Union Council (which is the smallest district administrative unit) and include Sihala and Shah Allah Ditta. While a village cluster (VC) will be the unit of randomization. Each VC will have 900-1400 population of women of reproductive age based within two to three contiguous catchment areas of the government employed community health workers called Lady Health Workers (LHWs). The reason for choosing village cluster as the unit of randomization is to minimize contamination/spillage between trial participants as the intervention will be delivered within community-based households. The intervention (KPZ) and control (EUC) village clusters will be geographically separated and the chance of intervention cluster participants regularly meeting control cluster participants will be negligible.
- Conditions
- Suicide, Suicide Prevention, Suicidal Ideation
- Being tested
- KPZ Program (KPZ), Enhanced Usual Care (EUC)
- Medical subject headings
- Suicide, Suicide Prevention, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPZ Program (KPZ)Behavioural
The KPZ package includes a culturally adapted approach to a co-designed safety plan. The assigned Peers will provide safety planning and Brief Contact Follow-Up. Contact follow up sessions will occur at the household level.
Enhanced Usual Care (EUC)Behavioural
Participants receive usual care enhanced by Lady Health Workers (LHWs) trained in WHO Mental Health Gap Action Programme (mhGAP) that will link at-risk women with the primary care facility based medical officer. The LHWs will follow the mhGAP protocol for imminent or low risk of suicide including ensuring the participant is safe, removing or reducing means, assigning a family member to ensure safety (if appropriate), providing psychoeducation, and referring and accompanying the individual to their primary care health center where a mhGAP trained doctor is staffed to resume care or make a referral to specialized care. Additionally, all women and healthcare workers are provided a 24 hour hotline number (hosted by a Pakistani based mental health organization called Taskeen) and are briefed on exactly what will happen if participant calls.
| Study group | Role | What they receive |
|---|---|---|
| KPZ Program (KPZ) | Experimental | Participants in this group will receive the KPZ program in addition to EUC. This group will receive the culturally adapted suicide prevention package (KPZ) of services delivered by trained Peers. The KPZ package includes a culturally adapted approach to a co-designed safety plan. The assigned Peers will provide safety planning and Brief Contact Follow-Up. Contact follow up sessions will occur at the household level. A Peer will be assigned an eligible mother and visit her within no less than 48 hours of enrollment. The first session will be delivered within two days of detection, and follow up contacts conducted by a trained Peer at 24 hours, every two days (for one week), weekly (for 1 month), and monthly (for 5 months), totaling 13 KPZ sessions in all. Contact assesses how the participant is coping, if the safety plan is helpful, adjustments to the safety plan, assessment of the suicide ideation and depression, and providing basic motivational interviewing and referral as needed. Receives: Behavioral: KPZ Program (KPZ); Behavioral: Enhanced Usual Care (EUC) |
| Enhanced Usual Care (EUC) | Active comparator | Participants in this group will receive usual care enhanced by Lady Health Workers (LHWs) trained in WHO Mental Health Gap Action Programme (mhGAP) that will link at-risk women with the primary care facility based medical officer. The LHWs will follow the mhGAP protocol for imminent or low risk of suicide including ensuring the participant is safe, removing or reducing means, assigning a family member to ensure safety (if appropriate), providing psychoeducation, and referring and accompanying the individual to their primary care health center where a mhGAP trained doctor is staffed to resume care or make a referral to specialized care. Additionally, all women and healthcare workers are provided a 24 hour hotline number (hosted by a Pakistani based mental health organization called Taskeen) and are briefed on exactly what will happen if participant calls. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 3 months and 6 months
Participants With 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).
Measured: baseline, 3 months and 6 months
Number Eligible Participants Who Consent
Number eligible participants approached who agreed to participate
Measured: Baseline
Number of Consented Participants Who Started Intervention (KPZ Arm Only)
Number consented participants who started intervention. Only collected in KPZ intervention arm.
Measured: Baseline
Number of Eligible Participants Who Completed KPZ Safety Card (KPZ Arm Only)
Number of eligible participants who completed KPZ safety card. Only collected in KPZ intervention arm.
Measured: 6 months
Number of Participants Who Completed One or More Brief Contact Follow up Session (KPZ Arm Only)
Number of participants who completed one or more brief contact follow up session. Only collected in KPZ intervention arm.
Measured: 6 months
Number of Participants Who Dropped Out of KPZ Intervention (KPZ Arm Only)
Number of participants who dropped out of KPZ intervention. Only collected in KPZ intervention arm.
Measured: 3 months and 6 months
Median Number of Intervention Sessions Completed (KPZ Arm Only)
Median number of intervention sessions completed by participants. Only collected in KPZ intervention arm.
Measured: 6 months
Number Participants Who Completed All Follow up Measures
Completion of follow-up assessments was defined as having non-missing data on all required primary and secondary outcome measures at the 6-month timepoint, including the PHQ-9, GAD-7, Beck Scale for Suicidal Ideation (BSSI), Multidimensional Scale of Perceived Social Support (MSPSS), Maternal Suicide Risk Index (MSRI), and Moral Injury Scale (MIS). Data were collected by trained independent assessors during structured in-person interview visits at 6 months post-randomization. Participants who attended the 6-month visit but had missing data on one or more scales due to refusal, inability to complete, or data collection error were classified as not fully complete. Of 50 enrolled participants, 44 (88%) completed all required follow-up measures at 6 months - 21 of 25 in the KPZ arm and 24 of 25 in the EUC arm.
Measured: 6 months
Percent Missing Items Per Participant
Mean percent of missing measure items per participant
Measured: 6 months
Secondary outcomes (7)
Mean Score on Sub-scales of the Feasibility Acceptability and Appropriateness Measures of Implementation (AIM/IAM) (Peers Only)
The Feasibility Implementation Measure (FIM), Acceptability of Intervention Measure (AIM), and Intervention Appropriateness Measure (IAM) are each 4-item self-report scales designed to assess implementation outcomes from the perspective of intervention deliverers. Items are rated on a 4-point Likert scale (1 = Completely Disagree, 2 = Somewhat Disagree, 3 = Somewhat Agree, 4 = Completely Agree). Items within each scale are averaged across the 4 items to yield a mean scale score for each scale (range 1-4). Higher scores indicate greater perceived feasibility, acceptability, and appropriateness respectively. A composite score is calculated as the sum of the three scale mean scores (range 3-12), where higher scores indicate more favorable overall implementation perceptions. These measures are collected among Peers only.
Measured: 6 months
Mean Score Knowledge, Attitudes, Self-efficacy, and Practice of Suicide Prevention (Peers Only)
The Knowledge, Attitudes, and Confidence Scale (KACS) assesses Peer capacity to deliver suicide prevention interventions across three domains. Items are rated on a 4-point scale (0 = None, 1 = Rarely, 2 = Some of the time, 3 = Most of the time), with negatively worded items reverse-scored prior to domain scoring. Domain raw scores are computed as the sum of items within each domain: Knowledge (6 items, raw range 0-18), Attitudes (13 items, raw range 0-39), and Confidence (11 items, raw range 0-33). Domain scores are then divided by the number of items in each domain to yield a per-item mean on a 0-3 scale for each domain. A composite score is computed as the mean of the three domain per-item means, also on a 0-3 scale. Higher scores indicate greater knowledge, more positive attitudes, and higher confidence in delivering the KPZ intervention. These measures are collected among Peers only.
Measured: 6 months
Mean Score Patient Health Questionnaire - 9 Item (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a validated 9-item self-report measure of depressive symptom severity over the past two weeks. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day). Items are summed to yield a total score ranging from 0 to 27, with higher scores indicating greater depressive symptom severity. Standard clinical severity thresholds are: 0-4 minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. A tenth item assessing functional impairment was administered separately and is not included in the total score. Values reported in the data table are total summed scores on the 0-27 scale.
Measured: baseline, 3 months and 6 months
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.
Measured: baseline, 3 months and 6 months
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. Total score range 7-84. Higher scores indicate more perceived social support.
Measured: baseline, 3 months and 6 months
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.
Measured: baseline, 3 months and 6 months
Number of Participants That Completed Qualitative Interviews
Qualitative Interviews with trial participants will elicit feasibility, acceptability, and perceived mechanisms of change.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start28 Nov 2024
- Primary completion25 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ashley K Hagaman, PhD MPH, Principal investigator, Yale School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208293
- Sponsor's protocol ID
- 2000030402
- Other IDs
- K01MH125142
- Acronym
- KPZ
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2024
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What data that will be shared: Data associated with the trial will be deposited at ICPSR (Inter-university Consortium for Political and Social Research) which is an NIH-funded repository. Submitted data will conform with relevant data and terminology standards. The ICPSR website can be found here https://www.icpsr.umich.edu/web/pages/ Who will have access to the data: Data will be deposited and made available through ICPSR which is an NIH-funded repository, and that these data will be shared with investigators requesting data working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes such as meta analyses.
Publications
Tanveer J, Hamid E, Saeed G, Mumtaz S, Ahmad M, Rahman S, Noor-Ul-Huda, Malik SS, Rao N, Rahman A, Malik A, Sikander S, Hagaman A. Peer-delivered systems-integrated suicide prevention for women in Pakistan: a protocol for hybrid type II pilot cluster randomized controlled trial. Pilot Feasibility Stud. 2026 Jun 13. doi: 10.1186/s40814-026-01841-7. Online ahead of print.
PubMed 42286769