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

Sponsor
Shannon E. Sauer-Zavala (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05816317
Collaborator
(none)
128
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Single-Session Mechanism-Focused Intervention (SSMFI)
  • Behavioral: Distress Tolerance Skills Review
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Testing a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single-Session Mechanism Focused Intervention (SSMFI)

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.

Active Comparator: Treatment as Usual

Behavioral: Distress Tolerance Skills Review
Treatment as usual at the inpatient setting for this study.

Outcome Measures

Primary Outcome Measures

  1. Change in Beck Hopelessness Scale [pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed]

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

  2. Change in Interpersonal Needs Questionnaire [pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed]

    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.

Secondary Outcome Measures

  1. Change in Columbia Suicide Severity Rating Scale [pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed]

    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.

  2. Change in Adult Suicidal Ideation Questionnaire [pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shannon E. Sauer-Zavala

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shannon E. Sauer-Zavala, Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier:
NCT05816317
Other Study ID Numbers:
  • 343205
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023