Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors
A Single-session Intervention for Suicidal Thoughts and Behaviors
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University Of Kentucky
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment as Usual
|
Treatment as usual at the inpatient setting for this study.
|
|
Experimental: Single-Session Mechanism Focused Intervention (SSMFI)
|
A brief intervention for patients hospitalized for suicide risk that directly targets hopelessness and perceptions of social relatedness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Beck Hopelessness Scale
Time Frame: 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.
|
pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
|
|
Change in Interpersonal Needs Questionnaire
Time Frame: 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.
|
pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
|
|
Change in hopelessness
Time Frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
How much are you feeling hopeless right now? (scale from "1" Not at all to "5" A lot)
|
Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
|
Change in wish to die
Time Frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
I wish to die this much: (scale from "0" Not at all to "8" Very much)
|
Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
|
Change in intensity of suicidal ideation
Time Frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
RATE OVERALL INTENSITY OF YOUR SUICIDAL IDEATION RIGHT NOW: (scale from "1" Extremely low intensity to "5" Extremely high intensity)
|
Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
|
Change in wish to live
Time Frame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
I wish to live this much: (scale from "0" Not at all to "8" Very much)
|
Pre-intervention and directly after the intervention (i.e., 1 hour later)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Columbia Suicide Severity Rating Scale
Time Frame: 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.
|
pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
|
|
Change in Adult Suicidal Ideation Questionnaire
Time Frame: 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.
|
pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shannon Sauer-Zavala, PhD, University Of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 343205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.