Clinical trial NCT03894462: Study About Treatment After a Suicide Attempt
Official title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: Zero Suicide
Effectiveness
Brief Treatment
Interpersonal Theory
Cost-Effectiveness
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Hutchings Psychiatric Center
name: University of Arkansas
name: State University of New York - Upstate Medical University
First posted: 2019-03-28
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Effective, brief, low-cost interventions for individuals who attempt suicide are needed to save lives and achieve the goals of the National Strategy for Suicide Prevention. In response to a National Institute for Mental Health (NIMH) Notice of Interest, this time-sensitive proposal leverages an existing federal investment in Zero Suicide to test the effectiveness of a highly promising new treatment for recent suicide attempt survivors and learn how it works. If hypotheses are supported, the study will provide evidence of a brief, practical, and cost-effective therapy that reduces suicide reattempts in a real-world health setting.

Detailed description: Suicide rates are rising in the US and more than a million Americans try to take their own lives each year. Effective, brief, low-cost interventions for individuals who attempt suicide are essential to saving lives and achieving the goals of the National Strategy for Suicide Prevention. This study takes advantage of a time-sensitive research opportunity to test the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a manualized 3-session intervention for recent suicide attempt survivors that produced dramatic reductions in suicide attempts in a efficacy trial-80% fewer reattempts and an average of 72% fewer hospital days over 24 months in the intervention group compared to controls. This research will now test its effectiveness of in the US public mental health care system, examine theoretically grounded mechanisms, and explore cost-effectiveness. ASSIP is currently being implemented by New York State in a Zero Suicide initiative funded by SAMHSA. Consistent with NIMH Notice of Interest MH-17-03, this project leverages this federal investment and a strong state partnership to conduct effectiveness research.

Effectiveness. The primary aim of this study is to determine the effectiveness of ASSIP in reducing suicide reattempts in a community mental health setting in the U.S. To accomplish this aim the investigators will conduct a randomized controlled trial with 400 individuals referred from psychiatric inpatient and emergency services following a suicide attempt. Participants will be randomized to receive either usual care + ASSIP (intervention arm) or usual care only (control arm), and followed for assessments at baseline, 6-weeks 3-, 6-, 12-, and 18-months.

Mechanism. The secondary aim of this study to examine the psychological mechanisms of ASSIP, as predicted by the Interpersonal Theory of Suicide. To accomplish this aim the investigators will conduct statistical analyses of a mediation model to determine (a) whether ASSIP improves perceptions of low belonging and being a burden on others, and (b) whether the effect of treatment on reductions in suicide re-attempts is mediated by these improvements.

Cost-Effectiveness. The exploratory aim is to identify potential implementation costs, barriers, and facilitators for delivering ASSIP. A stakeholder summary report will be written and disseminated, including an estimate, from the perspective of an ASSIP provider, the incremental cost per suicide attempt averted by delivering ASSIP to supplement usual care following a suicide attempt. This report can be used by organizations and localities considering implementing ASSIP as part of their Zero Suicide strategy.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older.
2. Suicide attempt within the past 60 days defined by intent to die using a standard item.
3. Ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up.

Exclusion Criteria:

1. Acute psychiatric instability (e.g., psychotic symptoms).
2. Inability to communicate in English (ASSIP is only provided by the clinic in English).
3. Residing outside of NYS (during the period eligible for ASSIP)

Primary outcomes:
measure: Time to Suicide Attempt
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: St. Joseph's Health Hospital
state: New York
city: Syracuse
country: United States
facility: Upstate University Hospital
state: New York
Study officials:
References:
citation: Gysin-Maillart A, Schwab S, Soravia L, Megert M, Michel K. A Novel Brief Therapy for Patients Who Attempt Suicide: A 24-months Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP). PLoS Med. 2016 Mar 1;13(3):e1001968. doi: 10.1371/journal.pmed.1001968. eCollection 2016 Mar.
citation: Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.