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Completed

NCT Number: NCT06208293

Suicide Prevention Integration Into Task-shifted Mental Health Interventions

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Islamabad Capital Territory

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KPZ Program (KPZ)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. Mean score Beck's Scale for Suicidal Ideation (BSI)

    Time frame: baseline, 3 months and 6 months

    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.

  2. Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS)

    Time frame: baseline, 3 months and 6 months

    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).

  3. Percent eligible participants who consent

    Time frame: 6 months

    Percent eligible participants who agreed to participate

  4. Percent of consented participants who started intervention

    Time frame: 6 months

    Percent consented participants who started intervention

  5. Percent of participants who completed KPZ safety card

    Time frame: 6 months

    Percent of participants enrolled who completed KPZ safety card

  6. Percent of participants who completed one brief contact follow up session

    Time frame: 6 months

    Percent of participants who completed one brief contact follow up session

  7. Percent of participants who dropped out of KPZ intervention

    Time frame: 3 months and 6 months

    Percent of participants who dropped out of KPZ intervention

  8. Median number of sessions completed

    Time frame: 6 months

    Median number of sessions completed by participants

  9. Percent participants who completed all follow up measures

    Time frame: 6 months

    Percent participants who completed all follow up measures

  10. Percent missing measure items per participant

    Time frame: 6 months

    Percent of missing measure items per participant

Secondary outcomes

  1. Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM).

    Time frame: 6 months

    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.

  2. Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention

    Time frame: 6 months

    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.

  3. Mean score Patient Health Questionnaire - 9 item (PHQ-9)

    Time frame: baseline, 3 months and 6 months

    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.

  4. Mean score Generalized Anxiety Disorder - 7 item (GAD-7)

    Time frame: baseline, 3 months and 6 months

    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.

  5. Mean score Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: baseline, 3 months and 6 months

    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.

  6. Mean score Maternal Suicide Cognitions Scale

    Time frame: baseline, 3 months and 6 months

    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.

  7. Qualitative Interviews

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Opportunities for Suicide Prevention Integration Into Task-shifted Mental Health Interventions in Low-resourced Contexts

Acronym: KPZ

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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