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
About this trial
This is an interventional treatment trial for Suicidal Ideation
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
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
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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