SuicideNCT04488055
Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)
A study testing Crisis Line Facilitation (CLF) in people with Suicide and Alcohol Use Disorder, run by University of Michigan at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Suicide, Alcohol Use Disorder
- What is being tested?
- Crisis Line Facilitation (CLF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2020to 17 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Detroit Rescue Mission Ministries
Detroit, Michigan, 48201
Meridian Health Services
Waterford, Michigan, 48327
About this study
Official title: 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.
- Conditions
- Suicide, Alcohol Use Disorder
- Being tested
- Crisis Line Facilitation (CLF), Enhanced Usual Care (EUC)
- Keywords
- National Suicide Prevention Lifeline
- Medical subject headings
- Suicide, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crisis Line Facilitation (CLF)Behavioural
CLF is a motivational interviewing-based intervention
Enhanced Usual Care (EUC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Crisis Line Facilitation (CLF) | Experimental | This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis. Receives: Behavioral: Crisis Line Facilitation (CLF) |
| Enhanced Usual Care (EUC) | Active comparator | 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. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (1)
Suicidal behavior
The Time Line Follow Back (TLFB) assessment will be the primary measure of suicidal behavior. Participants will report days with suicidal behavior.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start15 Oct 2020
- Primary completion10 Sep 2025
- Study completion17 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mark A. Ilgen, University of Michigan
- Investigators
- Mark Ilgen, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488055
- Sponsor's protocol ID
- HUM00164699
- Other IDs
- 5R01AA027513-05
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2020
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients
- ClinicalTrials.gov ID
- NCT04488055
- Acronym / sponsor ID
- HUM00164699
- Conditions
- Suicide, Alcohol Use Disorder
- Keywords
- National Suicide Prevention Lifeline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 17 Sep 2025 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crisis Line Facilitation (CLF) | Experimental | Behavioral: Crisis Line Facilitation (CLF)This single-session intervention addresses the individuals' perceived barriers and facilitators of crisis line use during periods of suicidal crisis. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crisis Line Facilitation (CLF)CLF is a motivational interviewing-based intervention | Behavioural | Crisis Line Facilitation (CLF) |
| 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. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
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.
1 secondary outcome
Suicidal behavior
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ilgen, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crisis Line Facilitation (CLF) in people with Suicide and Alcohol Use Disorder, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crisis line utilization (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.