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

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ClinicalTrials.gov Identifier: NCT04488055
Recruitment Status : Recruiting
First Posted : July 27, 2020
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Mark A. Ilgen, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Suicide Alcohol Use Disorder Behavioral: Crisis Line Facilitation (CLF) Behavioral: Enhanced Usual Care (EUC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Crisis Line Facilitation (CLF)
This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis.
 Behavioral: Crisis Line Facilitation (CLF)
CLF is a motivational interviewing-based intervention
Active Comparator: Enhanced Usual Care (EUC)
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.
 Behavioral: Enhanced Usual Care (EUC)
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.


Outcome Measures
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Primary Outcome Measures :
  1. Crisis line utilization [ Time Frame: Up to 12 months ]
    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 :
  1. Suicidal behavior [ Time Frame: Up to 12 months ]
    The Time Line Follow Back (TLFB) assessment will be the primary measure of suicidal behavior. Participants will report days with suicidal behavior.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488055


Contacts
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Contact: Noel Dockett 734-998-6652 ndockett@med.umich.edu

Locations
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United States, Michigan
Detroit Rescue Mission Ministries Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Noel Dockett    734-998-6652    ndockett@med.umich.edu   
Meridian Health Services Recruiting
Waterford, Michigan, United States, 48327
Contact: Noel Dockett    734-998-6652    ndockett@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Mark Ilgen, PhD University of Michigan
More Information
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Responsible Party: Mark A. Ilgen, Professor, Department of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT04488055    
Other Study ID Numbers: HUM00164699
1R01AA027513-01 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mark A. Ilgen, University of Michigan:
National Suicide Prevention Lifeline
Additional relevant MeSH terms:
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Alcoholism
Suicide
Self-Injurious Behavior
Behavioral Symptoms
 Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders