Study About Treatment After a Suicide Attempt

Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suicide, Attempted
• Intervention / Treatment: Behavioral: Zero Suicide Usual Care; Behavioral: Attempted Suicide Short Intervention Program

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony R Pisani, PhD; Phone Number: 585-275-3644; Email: anthony_pisani@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14604
      • University of Rochester Medical Center
    • Syracuse, New York, United States, 13210
      • Upstate University Hospital
    • Syracuse, New York, United States, 13203
      • St. Joseph's Health Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zero Suicide Usual Care; In Onondaga County, New York State (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 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 Office of Mental Health (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Suicide Attempt	Time from randomization to first suicide re-attempt	Up to 18 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Northwestern University; State University of New York - Upstate Medical University; University of Arkansas; Hutchings Psychiatric Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Effectiveness; Cost-Effectiveness; Zero Suicide; Brief Treatment; Interpersonal Theory
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: 3353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No