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

Primary Purpose

Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single-Session Mechanism-Focused Intervention (SSMFI)
Distress Tolerance Skills Review
Sponsored by
Shannon E. Sauer-Zavala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicidal Ideation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Single-Session Mechanism Focused Intervention (SSMFI)

    Treatment as Usual

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    March 29, 2023
    Last Updated
    April 13, 2023
    Sponsor
    Shannon E. Sauer-Zavala
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05816317
    Brief Title
    Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors
    Official Title
    Testing a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Shannon E. Sauer-Zavala

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicidal Ideation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single-Session Mechanism Focused Intervention (SSMFI)
    Arm Type
    Experimental
    Arm Title
    Treatment as Usual
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Single-Session Mechanism-Focused Intervention (SSMFI)
    Intervention Description
    A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Distress Tolerance Skills Review
    Intervention Description
    Treatment as usual at the inpatient setting for this study.
    Primary Outcome Measure Information:
    Title
    Change in Beck Hopelessness Scale
    Description
    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
    Title
    Change in Interpersonal Needs Questionnaire
    Description
    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 Outcome Measure Information:
    Title
    Change in Columbia Suicide Severity Rating Scale
    Description
    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
    Title
    Change in Adult Suicidal Ideation Questionnaire
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shannon Sauer-Zavala, PhD
    Phone
    (859) 562-1570
    Email
    tipslab@uky.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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