Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors

NCT ID: NCT05816317

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2025-05-20

Brief Summary

Across multiple models of suicide risk, hopelessness and perceptions of social relatedness (i.e., lack of social connection/thwarted belongingness, perceived burdensomeness) have emerged as candidate mechanisms that maintain STBs. Although these mechanisms have garnered strong empirical support in predicting STBs, there has been virtually no integration with interventions aimed for individuals at acute risk for suicide. Thus, the overarching goal of the present proposal is to evaluate a mechanism-focused intervention that explicitly targets two core mechanisms implicated in the maintenance of STBs: hopelessness and negative perceptions of social relatedness. Given that the period immediately following hospital discharge presents the highest risk for suicide attempts and up to 70% of patients admitted for a suicide attempt do not attend their first outpatient appointment, the intervention will be evaluated on an inpatient unit. Additionally, most of the extant interventions for STBs are administered across multiple sessions (i.e., 4 sessions and up to one year); however treatments of this length are unlikely to be feasible in acute care settings. Fortunately, very brief suicide prevention interventions, are effective in reducing future suicide attempts and increasing the likelihood of attending follow-up treatments. Additionally, single-session interventions (not suicide specific) have been shown to reduce hopelessness immediately and at a one-month follow-up.

The present study is an RCT comparing a novel Single Session Mechanism Focused Intervention (SSMFI) for STBs to treatment-as-usual (TAU) on a psychiatric inpatient unit for patients admitted for suicidal ideation or attempt. The engagement of the putative processes (hopelessness and negative perceptions of social relatedness) that maintain STBs will be assessed, along with the feasibility and acceptability of SSMFI for STBs on an inpatient psychiatric unit.

Conditions

Suicidal Ideation; Hopelessness; Wish to Live; Wish to Die

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single-Session Mechanism Focused Intervention (SSMFI)

Group Type: EXPERIMENTAL

Single-Session Mechanism-Focused Intervention (SSMFI)

Intervention Type: BEHAVIORAL

A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness.

Treatment as Usual

Group Type: ACTIVE_COMPARATOR

Distress Tolerance Skills Review

Intervention Type: BEHAVIORAL

Treatment as usual at the inpatient setting for this study.

Interventions

Single-Session Mechanism-Focused Intervention (SSMFI)

A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness.

Intervention Type: BEHAVIORAL

Distress Tolerance Skills Review

Treatment as usual at the inpatient setting for this study.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• admitted for care to the Adult Inpatient Unit at Good Samaritan Hospital
• endorse suicidal ideation and/or a recent suicide attempt (i.e., "a potentially self-injurious act committed with at least some wish to die") upon intake to the unit
• 18 years of age; (4) English speaking
• able to provide two methods for follow-up contact (i.e., phone number, email address) in order to complete study follow-up assessment.

Exclusion Criteria

• current manic episode
• acutely psychotic
• actively detoxicating from substances
• the inability to comprehend the intervention

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shannon E. Sauer-Zavala

OTHER

Sponsor Role: lead

Responsible Party

Shannon E. Sauer-Zavala

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shannon Sauer-Zavala, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

343205

Identifier Type: -

Identifier Source: org_study_id