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CompletedNCT05816317Updated Aug 1, 2025

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

An interventional study of Single-Session Mechanism-Focused Intervention (SSMFI) and Distress Tolerance Skills Review in Suicidal Ideation, Hopelessness and Wish to Live, sponsored by Shannon E. Sauer-Zavala. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-01.

Sponsored by Shannon E. Sauer-Zavala · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Suicidal Ideation
  • Hopelessness
  • Wish to Live
  • Wish to Die

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03

In context

Suicidal Ideation

515 studies on the registry are indexed under Suicidal Ideation; 195 are open to participants now.

This study's enrollment of 38 is below the median of 80 across 426 interventional studies indexed under Suicidal Ideation.

Browse Suicidal Ideation studies →

Lead sponsor

Shannon E. Sauer-Zavala is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Single-Session Mechanism Focused Intervention (SSMFI)

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

  • Active comparator
    Treatment as Usual

    Behavioral: Distress Tolerance Skills Review

Interventions

  • BehavioralSingle-Session Mechanism-Focused Intervention (SSMFI)

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

  • BehavioralDistress Tolerance Skills Review

    Treatment as usual at the inpatient setting for this study.

06

What researchers measure

Primary outcomes

  1. 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)

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

  2. Change in hopelessness

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

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

  3. Change in wish to live

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

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

  4. Change in wish to die

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

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

  5. 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.

    Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

  6. 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.

    Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

Secondary outcomes

  1. 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.

    Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

  2. 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.

    Time frame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed

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Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40506, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05816317
Lead sponsor
Shannon E. Sauer-Zavala
Responsible party
Shannon E. Sauer-Zavala (Associate Professor, University of Kentucky) — Sponsor-investigator
First posted
Apr 18, 2023
Start date
Oct 16, 2024
Primary completion
May 20, 2025
Completion
May 20, 2025
Last update
Aug 1, 2025

Study contacts

Shannon Sauer-Zavala, PhD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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