Clinical trial NCT06208293: Suicide Prevention Integration Into Task-shifted Mental Health Interventions
Official title: Opportunities for Suicide Prevention Integration Into Task-shifted Mental Health Interventions in Low-resourced Contexts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide
Suicide Prevention
Suicidal Ideation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-01-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean score Beck's Scale for Suicidal Ideation (BSI)
timeFrame: baseline, 3 months and 6 months
measure: Presence of any suicidal behaviors measured by the Columbia Suicide Severity Rating Scale (CSSRS)
timeFrame: baseline, 3 months and 6 months
measure: Percent eligible participants who consent
timeFrame: 6 months
measure: Percent of consented participants who started intervention
timeFrame: 6 months
measure: Percent of participants who completed KPZ safety card
timeFrame: 6 months
measure: Percent of participants who completed one brief contact follow up session
timeFrame: 6 months
measure: Percent of participants who dropped out of KPZ intervention
timeFrame: 3 months and 6 months
measure: Median number of sessions completed
timeFrame: 6 months
measure: Percent participants who completed all follow up measures
timeFrame: 6 months
measure: Percent missing measure items per participant
timeFrame: 6 months
Secondary outcomes:
measure: Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM).
timeFrame: 6 months
measure: Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention
timeFrame: 6 months
measure: Mean score Patient Health Questionnaire - 9 item (PHQ-9)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Generalized Anxiety Disorder - 7 item (GAD-7)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: baseline, 3 months and 6 months
measure: Mean score Maternal Suicide Cognitions Scale
timeFrame: baseline, 3 months and 6 months
measure: Qualitative Interviews
timeFrame: 6 months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Islamabad Capital Territory
Study officials:
affiliation: Yale School of Public Health
name: Ashley K Hagaman, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: