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

NCT05816317 | Completed

• 1 other identifier: 343205
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Change in intensity of suicidal ideation

  RATE OVERALL INTENSITY OF YOUR SUICIDAL IDEATION RIGHT NOW: (scale from "1" Extremely low intensity to "5" Extremely high intensity)

  Pre-intervention and directly after the intervention (i.e., 1 hour later)

• Change in hopelessness

  How much are you feeling hopeless right now? (scale from "1" Not at all to "5" A lot)

  Pre-intervention and directly after the intervention (i.e., 1 hour later)

• Change in wish to live

  I wish to live this much: (scale from "0" Not at all to "8" Very much)

  Pre-intervention and directly after the intervention (i.e., 1 hour later)

• Change in wish to die

  I wish to die this much: (scale from "0" Not at all to "8" Very much)

  Pre-intervention and directly after the intervention (i.e., 1 hour later)

• Change in Beck Hopelessness Scale

  Hopelessness will be measured with the Beck Hopelessness Scale. Scores range from 0-20 and higher scores indicate greater levels of hopelessness.

  pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

• Change in Interpersonal Needs Questionnaire

  Perceptions of social connectedness will be assessed with the Interpersonal Needs Questionnaire. Scores range from 0 to 107 with higher scores indicating less connection with others.

  pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Secondary Outcomes (2)

• Change in Columbia Suicide Severity Rating Scale

  pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

• Change in Adult Suicidal Ideation Questionnaire

  pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Study Arms (2)

Single-Session Mechanism Focused Intervention (SSMFI)

EXPERIMENTAL

Behavioral: Single-Session Mechanism-Focused Intervention (SSMFI)

Treatment as Usual

ACTIVE COMPARATOR

Behavioral: Distress Tolerance Skills Review

Interventions

Single-Session Mechanism-Focused Intervention (SSMFI) BEHAVIORAL

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

Single-Session Mechanism Focused Intervention (SSMFI)

Distress Tolerance Skills Review BEHAVIORAL

Treatment as usual at the inpatient setting for this study.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shannon E. Sauer-Zavala: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Shannon Sauer-Zavala, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 18, 2023
• Study Start: October 16, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)