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Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)

Primary Purpose

Suicide, Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crisis Line Facilitation (CLF)
Enhanced Usual Care (EUC)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring National Suicide Prevention Lifeline

Eligibility Criteria

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

Inclusion Criteria:

  • Probable alcohol use disorder within the past year based on an Alcohol Use Disorders Identification Test (AUDIT) score of 16 or greater
  • Report of a suicide attempt within the past year OR a lifetime suicide attempt more than a year ago and current suicide ideation within the past month based on a score of 5 or greater on the Beck Scale for Suicidal Ideation (BSS) or depression in the past month as measured by the Beck Depression Inventory with a of 20 or higher.

Exclusion Criteria:

  • Patients who do not understand English
  • Prisoners
  • Patients with profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments.

Sites / Locations

  • Detroit Rescue Mission MinistriesRecruiting
  • Meridian Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Crisis Line Facilitation (CLF)

Enhanced Usual Care (EUC)

Arm Description

This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis.

Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with the NSP Lifeline and a list of outpatient mental health and substance use resources and encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms.

Outcomes

Primary Outcome Measures

Crisis line utilization
The Time Line Follow Back (TLFB) assessment will be used as the primary measure of crisis line utilization. Participants will report days of utilization.

Secondary Outcome Measures

Suicidal behavior
The Time Line Follow Back (TLFB) assessment will be the primary measure of suicidal behavior. Participants will report days with suicidal behavior.

Full Information

First Posted
July 20, 2020
Last Updated
July 7, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04488055
Brief Title
Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)
Official Title
Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this research study is to learn about people who use the National Suicide Prevention (NSP) Lifeline during a suicidal crisis and those who don't. The researchers would also like to learn whether people who have experienced a suicidal crisis could benefit from participating in a therapy session about their thoughts and perceptions of the NSP Lifeline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Alcohol Use Disorder
Keywords
National Suicide Prevention Lifeline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crisis Line Facilitation (CLF)
Arm Type
Experimental
Arm Description
This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis.
Arm Title
Enhanced Usual Care (EUC)
Arm Type
Active Comparator
Arm Description
Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with the NSP Lifeline and a list of outpatient mental health and substance use resources and encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Line Facilitation (CLF)
Intervention Description
CLF is a motivational interviewing-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
In addition to receiving the brochure, EUC condition participants will meet with a therapist (in-person or remotely) for approximately 15 minutes for a descriptive overview of the brochure.
Primary Outcome Measure Information:
Title
Crisis line utilization
Description
The Time Line Follow Back (TLFB) assessment will be used as the primary measure of crisis line utilization. Participants will report days of utilization.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Suicidal behavior
Description
The Time Line Follow Back (TLFB) assessment will be the primary measure of suicidal behavior. Participants will report days with suicidal behavior.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Probable alcohol use disorder within the past year based on an Alcohol Use Disorders Identification Test (AUDIT) score of 16 or greater Report of a suicide attempt within the past year OR a lifetime suicide attempt more than a year ago and current suicide ideation within the past month based on a score of 5 or greater on the Beck Scale for Suicidal Ideation (BSS) or depression in the past month as measured by the Beck Depression Inventory with a of 20 or higher. Exclusion Criteria: Patients who do not understand English Prisoners Patients with profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Price, MS
Phone
734-998-6652
Email
amhprice@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Ilgen, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Detroit Rescue Mission Ministries
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Price, MS
Phone
734-998-6652
Email
amhprice@med.umich.edu
Facility Name
Meridian Health Services
City
Waterford
State/Province
Michigan
ZIP/Postal Code
48327
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Price, MS
Phone
734-998-6652
Email
amhprice@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)

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