Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03894462
Other study ID # 3353
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date February 28, 2025

Study information

Verified date October 2023
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Attempted Suicide Short Intervention Program
ASSIP is a manualized, three-session intervention, delivered either in-person or via telehealth: In Session 1, the therapist guides the patient in telling the story of their attempt. The session is video recorded. In Session 2, the therapist and patient sit side-by-side to view selections of the video, working together to understand the feelings and events that preceded the attempt. The patient is assigned a homework task. In Session 3, the therapist and patient create a summary of the suicide attempt and what led up to it, along with creating a personal safety plan.
Zero Suicide Usual Care
Participants will have access to outpatient treatment in facilities that are adopting NYS Zero Suicide protocols. Those who do not engage in care will nonetheless experience enhanced transition and follow-up contact from the services from which they are discharged.

Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York
United States St. Joseph's Health Hospital Syracuse New York
United States Upstate University Hospital Syracuse New York

Sponsors (5)

Lead Sponsor Collaborator
University of Rochester Hutchings Psychiatric Center, Northwestern University, State University of New York - Upstate Medical University, University of Arkansas

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Suicide Attempt Time from randomization to first suicide re-attempt Up to 18 months
See also
  Status Clinical Trial Phase
Recruiting NCT03185026 - Psychoeducation for Suicidal Behavior N/A
Recruiting NCT05609487 - Evaluation of the Safety Plan to Prevent Suicidal Reiteration N/A
Recruiting NCT06322199 - Differences Between Suicide Attempters and Suicide Ideators. Influence of the Brief Therapy Attempted Suicide Short Intervention Program (ASSIP) on Neuropsychological Correlates and Psychological Process Factors - Project 3
Completed NCT03134885 - Evaluation of a Regional Post-discharge Monitoring System for Suicide Attempters
Completed NCT01535482 - Cognitive Therapy for Suicidal Older Men N/A
Completed NCT01360736 - A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) N/A
Completed NCT01118208 - Blister Packaging Medication to Increase Treatment Adherence and Clinical Response N/A
Completed NCT05580757 - Pharmacists as Gate Keepers in Suicide Prevention: Needs of Pharmacists
Not yet recruiting NCT05427734 - Treating Drivers of Suicide Using Jaspr Health N/A
Recruiting NCT06406972 - Brief Admission by Self-referral for Individuals With Self-harm: Effects on Compulsory Care
Recruiting NCT05537376 - A Novel Peer-Delivered Recovery-Focused Suicide Prevention Intervention for Veterans With Serious Mental Illness N/A
Completed NCT03227991 - Safety Planning Intervention to Reduce Short Term Risk N/A
Recruiting NCT04962373 - Brief Admission for Adolescents Who Self-harm
Completed NCT02985047 - Brief Admission Skane: Replacing General Admission for Individuals With Self-harm and Acute Risk of Suicide N/A
Enrolling by invitation NCT06060535 - Implementation of Suicide Risk Models in Health Systems N/A
Recruiting NCT04994873 - Skills to Enhance Positivity in Suicidal Youth N/A
Recruiting NCT04592809 - Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents Phase 3
Completed NCT01176929 - Randomized Controlled and Prospective Trial of a Cohort of People Who Made a Suicide Attempt N/A
Completed NCT00558805 - Family Intervention for Suicidal Youth: Emergency Care Phase 2
Recruiting NCT05390918 - Targeting Adolescent Insomnia to Lessen Overall Risk of Suicidal Behavior N/A