Alcohol UseNCT06845761
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making
A study testing Self-Guided Cognitive Behavioral Therapy in people with Alcohol Use and Suicidal Ideation/Behavior, run by Mark J Rzeszutek, PhD at 1 site in United States.
Trial summary
The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use, Suicidal Ideation/Behavior
- What is being tested?
- Self-Guided Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2025to 23 Aug 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Consume alcohol at least weekly
- A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
- Some interest in cutting back on drinking or quitting
- Read and understand English
Who cannot join
- A score of 31 or greater on the Alcohol Use Disorder Identification Test (AUDIT) at baseline
- Reporting schizophrenia and/or other psychiatric diagnoses other than depression or anxiety at baseline
- Already being in treatment for alcohol use disorder at baseline
- Past month substance use other than cannabis or tobacco
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults.
Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.
- Conditions
- Alcohol Use, Suicidal Ideation/Behavior
- Being tested
- Self-Guided Cognitive Behavioral Therapy
- Keywords
- Alcohol, Cognitive Behavioral Therapy, Suicide, Remote, Self-Guided Therapy, CBT4CBT
- Medical subject headings
- Alcohol Drinking, Suicidal Ideation, Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Guided Cognitive Behavioral TherapyBehavioural
Also called Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)
Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) is a set of seven modules that consist of different skills trainings that can be accessed by devices with an internet connection. The version of CBT4CBT that will be provided is the alcohol-based CBT4CBT.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy | Experimental | Participants in this arm will complete four assessments, one at baseline, then another three one month apart. Participants will be given access to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) at the end of their baseline session. Receives: Behavioral: Self-Guided Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use
Participants will complete baseline and remote follow-up assessments. Alcohol use will be measured by timeline follow-back of alcohol use for the previous 4 weeks of time of assessment. General linear mixed-effects modeling will be used to assess changes in alcohol use.
Measured: Assessed at study week 0, 4, 8, and 12
Engagement with Self-Guided Cognitive Behavioral Therapy for Alcohol Use
At the end of the study, participant engagement with Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) modules will be analyzed with ordinary linear regression. Engagement will be defined as the proportion of modules completed.
Measured: Assessed at study week 12
Change in Suicidal Thoughts and Behaviors
Participants will complete baseline and remote follow-up assessments. Suicidal thoughts and behaviors will be will be measured by the Colombia Suicide Severity Rating Scale. Suicidal ideation severity is measured from a scale of 0 to 25, where higher scores indicate higher levels of suicidal ideation severity. General linear mixed-effects modeling will be used to assess changes in suicidal thoughts and behaviors.
Measured: Assessed at study week 0, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start9 May 2025
- Primary completion23 Aug 2026
- Study completion23 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark J Rzeszutek, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Mark J Rzeszutek, PhD, University of Kentucky
- Investigators
- Mark J Rzeszutek, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845761
- Sponsor's protocol ID
- 97418
- Other IDs
- K99AA031309-01A1
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data from this study will be made as available as possible either after the end of the funding period or after acceptance for publication, whichever comes first. All shared data will comply with HIPAA guidelines on personally identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making
- ClinicalTrials.gov ID
- NCT06845761
- Acronym / sponsor ID
- 97418
- Conditions
- Alcohol Use, Suicidal Ideation/Behavior
- Keywords
- Alcohol, Cognitive Behavioral Therapy, Suicide, Remote, Self-Guided Therapy, CBT4CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mark J Rzeszutek, PhDUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 9 May 2025 (actual)
- Primary completion
- 23 Aug 2026 (actual)
- Study completion
- 23 Aug 2026 (actual)
- First posted
- 25 Feb 2025 (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 single groups trial is to (Aim 1) determine relationships between alcohol use, suicidal thoughts and behaviors (STBs), and behavioral economic decision-making in a community sample (N = 100) of alcohol using adults who are 18 years of age or older, (Aim 2) is to determine factors that predict engagement with a remote intervention (computer based training for cognitive behavioral therapy; CBT4CBT) for alcohol and its effects on alcohol use, STBs, and decision-making with those same adults.
Participants will complete a baseline assessment and be given access for remote, self-guided CBT4CBT modules for alcohol use. Following this, participants will remotely complete three follow-up assessments over three months. This will allow for determination of incidence and predictors of alcohol use and STBs and determination of predictors of engagement and efficacy of a remote intervention for alcohol use in both samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy | Experimental | Behavioral: Self-Guided Cognitive Behavioral TherapyParticipants in this arm will complete four assessments, one at baseline, then another three one month apart. Participants will be given access to Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) at the end of their baseline session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Consume alcohol at least weekly
- A score of 8 or greater on the Alcohol Use Disorder Identification Test (AUDIT)
- Some interest in cutting back on drinking or quitting
- Read and understand English
Key exclusion criteria (4 listed)
- A score of 31 or greater on the Alcohol Use Disorder Identification Test (AUDIT) at baseline
- Reporting schizophrenia and/or other psychiatric diagnoses other than depression or anxiety at baseline
- Already being in treatment for alcohol use disorder at baseline
- Past month substance use other than cannabis or tobacco
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 |
|---|---|---|
| Self-Guided Cognitive Behavioral TherapyAlso: Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT)Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) is a set of seven modules that consist of different skills trainings that can be accessed by devices with an internet connection. The version of CBT4CBT that will be provided is the alcohol-based CBT4CBT. | Behavioural | Alcohol-Based Computer Based Training for Cognitive Behavioral Therapy |
Primary outcome
Change in Alcohol Use
Time frame: Assessed at study week 0, 4, 8, and 12
Participants will complete baseline and remote follow-up assessments. Alcohol use will be measured by timeline follow-back of alcohol use for the previous 4 weeks of time of assessment. General linear mixed-effects modeling will be used to assess changes in alcohol use.
Engagement with Self-Guided Cognitive Behavioral Therapy for Alcohol Use
Time frame: Assessed at study week 12
At the end of the study, participant engagement with Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) modules will be analyzed with ordinary linear regression. Engagement will be defined as the proportion of modules completed.
Change in Suicidal Thoughts and Behaviors
Time frame: Assessed at study week 0, 4, 8, and 12
Participants will complete baseline and remote follow-up assessments. Suicidal thoughts and behaviors will be will be measured by the Colombia Suicide Severity Rating Scale. Suicidal ideation severity is measured from a scale of 0 to 25, where higher scores indicate higher levels of suicidal ideation severity. General linear mixed-effects modeling will be used to assess changes in suicidal thoughts and behaviors.
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 2 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified data from this study will be made as available as possible either after the end of the funding period or after acceptance for publication, whichever comes first. All shared data will comply with HIPAA guidelines on personally identifiable information.
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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 J Rzeszutek, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Guided Cognitive Behavioral Therapy in people with Alcohol Use and Suicidal Ideation/Behavior, run by Mark J Rzeszutek, PhD at 1 site 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 5 inclusion and 4 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 2 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 1 site 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?
Change in Alcohol Use (time frame: Assessed at study week 0, 4, 8, and 12). The study lists 3 primary outcomes in all. 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 2 Sep 2026.