Suicide Prevention Integration Into Task-shifted Mental Health Interventions

NCT ID: NCT06208293

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2026-01-31

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

KPZ Program (KPZ)

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.

Group Type: EXPERIMENTAL

KPZ Program (KPZ)

Intervention Type: 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)

Intervention Type: 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.

Enhanced Usual Care (EUC)

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type: 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.

Interventions

KPZ Program (KPZ)

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.

Intervention Type: BEHAVIORAL

Enhanced Usual Care (EUC)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Women requiring immediate inpatient care for any reason (medical or psychiatric)
• Women who do not speak and/or comprehend Urdu language

• Women with untreated suicidality
• Women who do not speak and/or comprehend Urdu language

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley K Hagaman, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Yale School of Public Health

Locations

Islamabad Capital Territory

Islamabad, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Ashley K Hagaman, PhD MPH

Role: CONTACT

ashley.hagaman@yale.edu

2487908954

Other Identifiers

K01MH125142

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000030402

Identifier Type: -

Identifier Source: org_study_id