Suicide Prevention Integration Into Task-shifted Mental Health Interventions

Suicide Clinical Trial

— KPZ  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208293
• Other study ID #: 2000030402
• Secondary ID: K01MH125142
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Ashley K Hagaman, PhD MPH
• Phone: 2487908954
• Email: ashley.hagaman[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Prevention

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	Islamabad Capital Territory	Islamabad

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percent eligible participants who consent	Percent eligible participants who agreed to participate	6 months
Primary	Percent of consented participants who started intervention	Percent consented participants who started intervention	6 months
Primary	Percent of participants who completed KPZ safety card	Percent of participants enrolled who completed KPZ safety card	6 months
Primary	Percent of participants who completed one brief contact follow up session	Percent of participants who completed one brief contact follow up session	6 months
Primary	Percent of participants who dropped out of KPZ intervention	Percent of participants who dropped out of KPZ intervention	3 months and 6 months
Primary	Median number of sessions completed	Median number of sessions completed by participants	6 months
Primary	Percent participants who completed all follow up measures	Percent participants who completed all follow up measures	6 months
Primary	Percent missing measure items per participant	Percent of missing measure items per participant	6 months
Secondary	Mean score on sub-scales of the Feasibility Acceptability and Appropriateness Measures of implementation (AIM/IAM).	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.	6 months
Secondary	Mean score Knowledge, Attitudes, Self-efficacy, and practice of suicide prevention	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.	6 months
Secondary	Mean score Patient Health Questionnaire - 9 item (PHQ-9)	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.	baseline, 3 months and 6 months
Secondary	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.	baseline, 3 months and 6 months
Secondary	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, then divide by 12. Total score range from 1 to 7. Higher scores indicate more perceived social support.	baseline, 3 months and 6 months
Secondary	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.	baseline, 3 months and 6 months
Secondary	Qualitative Interviews	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.	6 months