Suicide Prevention Integration Into Task-shifted Mental Health Interventions

NCT06208293 | Completed

• 2 other identifiers: 2000030402K01MH125142
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Suicide Prevention; Suicidal Ideation

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• Percent eligible participants who consent

  Percent eligible participants who agreed to participate

  6 months

• Percent of consented participants who started intervention

  Percent consented participants who started intervention

  6 months

• Percent of participants who completed KPZ safety card

  Percent of participants enrolled who completed KPZ safety card

  6 months

• Percent of participants who completed one brief contact follow up session

  Percent of participants who completed one brief contact follow up session

  6 months

• Percent of participants who dropped out of KPZ intervention

  Percent of participants who dropped out of KPZ intervention

  3 months and 6 months

• Median number of sessions completed

  Median number of sessions completed by participants

  6 months

• Percent participants who completed all follow up measures

  Percent participants who completed all follow up measures

  6 months

• Percent missing measure items per participant

  Percent of missing measure items per participant

  6 months

Secondary Outcomes (7)

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

  6 months

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

  6 months

• Mean score Patient Health Questionnaire - 9 item (PHQ-9)

  baseline, 3 months and 6 months

• Mean score Generalized Anxiety Disorder - 7 item (GAD-7)

  baseline, 3 months and 6 months

• Mean score Multidimensional Scale of Perceived Social Support (MSPSS)

  baseline, 3 months and 6 months

Study Arms (2)

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.

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.

Behavioral: Enhanced Usual Care (EUC)

Interventions

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.

KPZ Program (KPZ)

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.

Enhanced Usual Care (EUC); KPZ Program (KPZ)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Yale University: lead

Study Sites (1)

Islamabad Capital Territory

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Suicide; Suicide Prevention; Suicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Ashley K Hagaman, PhD MPH

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 17, 2024
• Study Start: November 28, 2024
• Primary Completion: June 25, 2025
• Study Completion: June 25, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available as soon as possible but no later than within two years of the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier.
• Access Criteria: Outcome data will be deposited in the ICPSR repository as soon as possible but no later than within two years of the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier. Investigators will identify where the data will be available and how to access the data in any publications and presentations that we author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. ICPSR has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.

Locations

PA (1)