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

Suicidal Ideation Clinical Trial

Official title:

A Single-session Intervention for Suicidal Thoughts and Behaviors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05816317
• Other study ID #: 343205
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: Shannon Sauer-Zavala, PhD
• Phone: (859) 562-1570
• Email: tipslab[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• Single-Session Mechanism-Focused Intervention (SSMFI)
A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness.
• Distress Tolerance Skills Review
Treatment as usual at the inpatient setting for this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shannon E. Sauer-Zavala

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Columbia Suicide Severity Rating Scale	The self-report version of the Columbia Suicide Severity Rating Scale will be used to assess the presence of suicidal behaviors thoughts and behaviors. Participants are asked to respond Yes/No to 6 items that refer to various suicide related phenomena (thoughts, planning, intent, and behaviors). There is no total score for this measure.	pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Secondary	Change in Adult Suicidal Ideation Questionnaire	Intensity of suicidal ideation will be measured with the Adult Suicidal Ideation Questionnaire. Scores range from 0-150 and higher scores indicate greater intensity of suicidal ideation.	pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed