Study About Treatment After a Suicide Attempt

• ClinicalTrials.gov Identifier: NCT03894462
• Recruitment Status: Recruiting
• First Posted: March 28, 2019
• Last Update Posted: December 9, 2020
• Sponsor: University of Rochester
• Collaborators: Northwestern University; Hutchings Psychiatric Center; University of Arkansas; State University of New York - Upstate Medical University
• Information provided by (Responsible Party): Anthony Pisani, University of Rochester

Study Description

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 an 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.

Condition or disease	Intervention/treatment	Phase
Suicide, Attempted	Behavioral: Attempted Suicide Short Intervention Program; Behavioral: Zero Suicide Usual Care	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial
• Masking: Single (Care Provider)
• Masking Description: We do not inform providers giving usual care whether their patients are receiving ASSIP. However, providers may find out through ordinary course of usual care being provided.
• Primary Purpose: Prevention
• Official Title: Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
• Actual Study Start Date: October 8, 2020
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Zero Suicide Usual Care; In Onondaga County, NYS aims to implement a countywide "Zero Suicide Safety Net" of providers who share enhanced protocols for clinical care, staff training, and data collection (improved EMR coding of suicidal behavior). Participating behavioral health systems have agreed to common protocols for clinical care, training, and data collection. Participating providers receive robust training in suicide prevention best practices. Because of the wide participation of mental health facilities in the NYS-OMH Zero Suicide project, most subjects who engage in outpatient treatment will receive that 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.	Behavioral: 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.
Experimental: Zero Suicide Usual Care + ASSIP; Patients in this treatment arm will receive ASSIP brief therapy in addition to being able to access any usual care as recommended by their provider. 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Time to Suicide Attempt [ Time Frame: Up to 18 months ]
   Time from randomization to first suicide re-attempt

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Anthony R Pisani, PhD; 585-275-3644; anthony_pisani@urmc.rochester.edu

Locations

United States, New York

University of Rochester Medical Center; Recruiting

Rochester, New York, United States, 14604

Contact: Anthony Pisani, PhD

St. Joseph's Health Hospital; Recruiting

Syracuse, New York, United States, 13203

Contact: Jessica Caruso, RN

Upstate University Hospital; Recruiting

Syracuse, New York, United States, 13210

Contact: Seetha Ramanathan, MD

Sponsors and Collaborators

University of Rochester

Northwestern University

Hutchings Psychiatric Center

University of Arkansas

State University of New York - Upstate Medical University

More Information

Publications:

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.

• Responsible Party: Anthony Pisani, Principal Investigator, University of Rochester
• ClinicalTrials.gov Identifier: NCT03894462
• Other Study ID Numbers: 3353
• First Posted: March 28, 2019
• Last Update Posted: December 9, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony Pisani, University of Rochester:

Zero Suicide; Effectiveness; Brief Treatment; Interpersonal Theory; Cost-Effectiveness

Additional relevant MeSH terms:

Suicide; Suicide, Attempted; Self-Injurious Behavior; Behavioral Symptoms