Alcohol Use DisorderNCT02742246
Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders
A study testing Individual clinician-provided CBT and CBT4CBT in people with Alcohol Use Disorder, run by Yale University at 2 sites in United States.
Trial summary
Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Individual clinician-provided CBT and CBT4CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Individuals will be included who:
- Are 18 years of age or older.
- Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days,
- Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up
- Are willing to provide locator information for follow-up, and
- Are fluent in English and have a 6th grade or higher reading level.
Who cannot join
- Individuals will be excluded who:
- Have an untreated bipolar or schizophrenic disorder,
- Have a current legal case pending such that incarceration during the 8-week protocol is likely,
- Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or
- Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MCCA
Bridgeport, Connecticut, 06604
SATU
New Haven, Connecticut, 06511
About this study
Official title: Efficacy and Mechanisms of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorders
Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use
Read the detailed description
Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.
- Conditions
- Alcohol Use Disorder
- Being tested
- Individual clinician-provided CBT, CBT4CBT
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual clinician-provided CBTBehavioural
Individual clinician-provided CBT
CBT4CBTBehavioural
CBT computer program assisted therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment as usual (TAU) | No intervention | This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| Individual clinician-provided CBT | Active comparator | This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. Receives: Behavioral: Individual clinician-provided CBT |
| CBT4CBT | Experimental | In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. Receives: Behavioral: CBT4CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.
Measured: Baseline up to 8 weeks
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly.
Measured: from end of treatment at week 8 up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study start14 Feb 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Brian Kiluk, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742246
- Sponsor's protocol ID
- 1511016759
- Other IDs
- 1R01AA024122-01A1, 1K02AA027300-01A1
- Status last verified
- Nov 2023
- First submitted
- 8 Apr 2016
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiluk BD, Benitez B, DeVito EE, Frankforter TL, LaPaglia DM, O'Malley SS, Nich C. A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435205. doi: 10.1001/jamanetworkopen.2024.35205.
PubMed 39325452
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT02742246
- Acronym / sponsor ID
- 1511016759
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Posted 28 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use
Detailed description
Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard treatment as usual (TAU) | No intervention | –This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| Individual clinician-provided CBT | Active comparator | Behavioral: Individual clinician-provided CBTThis is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
| CBT4CBT | Experimental | Behavioral: CBT4CBTIn this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 years of age or older.
- Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days,
- Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up
- Are willing to provide locator information for follow-up, and
- Are fluent in English and have a 6th grade or higher reading level.
Key exclusion criteria (5 listed)
- Have an untreated bipolar or schizophrenic disorder,
- Have a current legal case pending such that incarceration during the 8-week protocol is likely,
- Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or
- Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).
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 |
|---|---|---|
| Individual clinician-provided CBTIndividual clinician-provided CBT | Behavioural | Individual clinician-provided CBT |
| CBT4CBTCBT computer program assisted therapy | Behavioural | CBT4CBT |
Primary outcome
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
Time frame: Baseline up to 8 weeks
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
Time frame: from end of treatment at week 8 up to 6 months
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39325452Kiluk BD, Benitez B, DeVito EE, Frankforter TL, LaPaglia DM, O'Malley SS, Nich C. A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435205. doi: 10.1001/jamanetworkopen.2024.35205.
- 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.
Brian Kiluk, PhD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual clinician-provided CBT and CBT4CBT in people with Alcohol Use Disorder, run by Yale University 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 6 inclusion and 5 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 18 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 28 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back (time frame: Baseline up to 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02742246, which also lists 1 linked publication.
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 18 Nov 2023.