Clinical trial NCT05816317: Randomized Controlled Trial of a Single-session Mechanism-focused Intervention for Suicidal Thoughts and Behaviors
Official title: A Single-session Intervention for Suicidal Thoughts and Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Hopelessness
Wish to Live
Wish to Die
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in tntensity of suicidal ideation
timeFrame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
measure: Change in hopelessness
timeFrame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
measure: Change in wisht to live
timeFrame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
measure: Change in wish to die
timeFrame: Pre-intervention and directly after the intervention (i.e., 1 hour later)
measure: Change in Beck Hopelessness Scale
timeFrame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
measure: Change in Interpersonal Needs Questionnaire
timeFrame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Secondary outcomes:
measure: Change in Columbia Suicide Severity Rating Scale
timeFrame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
measure: Change in Adult Suicidal Ideation Questionnaire
timeFrame: pre-intervention, 1 week after the intervention is completed, 1 month after the intervention is completed
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Shannon Sauer-Zavala, PhD
role: PRINCIPAL_INVESTIGATOR
References: