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Study About Treatment After a Suicide Attempt

Primary Purpose

Suicide, Attempted

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attempted Suicide Short Intervention Program
Zero Suicide Usual Care
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring Zero Suicide, Effectiveness, Brief Treatment, Interpersonal Theory, Cost-Effectiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Rochester Medical Center
  • St. Joseph's Health Hospital
  • Upstate University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Zero Suicide Usual Care

Zero Suicide Usual Care + ASSIP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to Suicide Attempt
Time from randomization to first suicide re-attempt

Secondary Outcome Measures

Full Information

First Posted
February 12, 2019
Last Updated
October 2, 2023
Sponsor
University of Rochester
Collaborators
Northwestern University, Hutchings Psychiatric Center, University of Arkansas, State University of New York - Upstate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03894462
Brief Title
Study About Treatment After a Suicide Attempt
Official Title
Effectiveness of a Targeted Brief Intervention for Recent Suicide Attempt Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Northwestern University, Hutchings Psychiatric Center, University of Arkansas, State University of New York - Upstate Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Zero Suicide, Effectiveness, Brief Treatment, Interpersonal Theory, Cost-Effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
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.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zero Suicide Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Zero Suicide Usual Care + ASSIP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attempted Suicide Short Intervention Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Zero Suicide Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Suicide Attempt
Description
Time from randomization to first suicide re-attempt
Time Frame
Up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older. Suicide attempt within the past 60 days defined by intent to die using a standard item. 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: Acute psychiatric instability (e.g., psychotic symptoms). Inability to communicate in English (ASSIP is only provided by the clinic in English). Residing outside of NYS (during the period eligible for ASSIP)
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14604
Country
United States
Facility Name
St. Joseph's Health Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
Upstate University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26930055
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.
Results Reference
background
PubMed Identifier
33884617
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.
Results Reference
derived

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Study About Treatment After a Suicide Attempt

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