- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488055
Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)
July 7, 2023 updated by: Mark A. Ilgen, University of Michigan
Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amanda Price, MS
- Phone Number: 734-998-6652
- Email: amhprice@med.umich.edu
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Recruiting
- Detroit Rescue Mission Ministries
-
Contact:
- Amanda Price, MS
- Phone Number: 734-998-6652
- Email: amhprice@med.umich.edu
-
Waterford, Michigan, United States, 48327
- Recruiting
- Meridian Health Services
-
Contact:
- Amanda Price, MS
- Phone Number: 734-998-6652
- Email: amhprice@med.umich.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Ilgen, PhD, University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2020
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 24, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 7, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00164699
- 1R01AA027513-01 (U.S. NIH Grant/Contract)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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