Alcohol Abuse or DependenceCBT4CBT EtohNCT01615497
Web-based CBT4CBT for Alcohol
A study testing Standard Treatment as Usual (TAU), Web-based CBT4CBT for alcohol plus TAU and Web-based CBT with minimal clinical contact in people with Alcohol Abuse or Dependence, run by Yale University at 2 sites in United States.
Trial summary
The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Abuse or Dependence
- What is being tested?
- Standard Treatment as Usual (TAU), Web-based CBT4CBT for alcohol plus TAU and Web-based CBT with minimal clinical contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2012to Jun 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years of age or older.
- Are applying for outpatient, non-agonist substance abuse treatment at SATU.
- Meet current DSM-IV criteria for alcohol abuse or dependence.
- Are sufficiently stable for 8 weeks of outpatient treatment.
- Can commit to 8 weeks of treatment and are willing to be randomized to treatment
- Are willing to provide locator information for follow-up.
- Are fluent in English and have a 6th grader or higher reading level
Who cannot join
- Have an untreated bipolar or schizophrenic disorder.
- Who have a current legal case pending such that incarceration during 8-week protocol is likely.
- Are physically dependent on alcohol, opioids or benzodiazepines
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Substance Abuse Treatment Unit (SATU)
New Haven, Connecticut, 06511
Substance Abuse Treatment Unit (SATU)
New Haven, Connecticut, 06519
About this study
Official title: Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol
The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.
Read the detailed description
Ninety alcohol using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) standard outpatient counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.
- Conditions
- Alcohol Abuse or Dependence
- Being tested
- Standard Treatment as Usual (TAU), Web-based CBT4CBT for alcohol plus TAU, Web-based CBT with minimal clinical contact
- Keywords
- cognitive behavior therapy, computer assisted instruction, alcohol abuse therapy, educational resource design and development
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Treatment as Usual (TAU)Behavioural
Treatment normally offered at this clinic which could include individual or group alcohol and drug counseling sessions one time per week lasting one hour each time.
Web-based CBT4CBT for alcohol plus TAUBehavioural
Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU
Web-based CBT with minimal clinical contactBehavioural
Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment as Usual (TAU) | Active comparator | Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on alcohol and substance abuse. Receives: Behavioral: Standard Treatment as Usual (TAU) |
| Web-based CBT4CBT for alcohol plus TAU | Experimental | A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. plus standard treatment as usual. Receives: Behavioral: Web-based CBT4CBT for alcohol plus TAU |
| Web-based CBT with minimal clinical contact | Active comparator | A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug and alcohol use, coping with cravings, etc. plus 10 minute check in with clinician. Receives: Behavioral: Web-based CBT with minimal clinical contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in alcohol use
Measured: 8 weeks
Secondary outcomes (1)
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Abuse or DependenceStudies 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Kathleen Carroll, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615497
- Sponsor's protocol ID
- 1204010157
- Other IDs
- R21AA021405-01
- Acronym
- CBT4CBT Etoh
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2012
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kiluk BD, Devore KA, Buck MB, Nich C, Frankforter TL, LaPaglia DM, Yates BT, Gordon MA, Carroll KM. Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Alcohol Clin Exp Res. 2016 Sep;40(9):1991-2000. doi: 10.1111/acer.13162. Epub 2016 Aug 4.
PubMed 27488212
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol
- ClinicalTrials.gov ID
- NCT01615497
- Acronym / sponsor ID
- CBT4CBT Etoh / 1204010157
- Conditions
- Alcohol Abuse or Dependence
- Keywords
- cognitive behavior therapy, computer assisted instruction, alcohol abuse therapy, educational resource design and development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jun 2012 (estimated)
- 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 investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.
Detailed description
Ninety alcohol using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) standard outpatient counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.
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) | Active comparator | Behavioral: Standard Treatment as Usual (TAU)Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on alcohol and substance abuse. |
| Web-based CBT4CBT for alcohol plus TAU | Experimental | Behavioral: Web-based CBT4CBT for alcohol plus TAUA computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. plus standard treatment as usual. |
| Web-based CBT with minimal clinical contact | Active comparator | Behavioral: Web-based CBT with minimal clinical contactA computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug and alcohol use, coping with cravings, etc. plus 10 minute check in with clinician. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are 18 years of age or older.
- Are applying for outpatient, non-agonist substance abuse treatment at SATU.
- Meet current DSM-IV criteria for alcohol abuse or dependence.
- Are sufficiently stable for 8 weeks of outpatient treatment.
- Can commit to 8 weeks of treatment and are willing to be randomized to treatment
Key exclusion criteria (3 listed)
- Have an untreated bipolar or schizophrenic disorder.
- Who have a current legal case pending such that incarceration during 8-week protocol is likely.
- Are physically dependent on alcohol, opioids or benzodiazepines
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 |
|---|---|---|
| Standard Treatment as Usual (TAU)Treatment normally offered at this clinic which could include individual or group alcohol and drug counseling sessions one time per week lasting one hour each time. | Behavioural | Standard Treatment as Usual (TAU) |
| Web-based CBT4CBT for alcohol plus TAUSubjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU | Behavioural | Web-based CBT4CBT for alcohol plus TAU |
| Web-based CBT with minimal clinical contactSubjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician. | Behavioural | Web-based CBT with minimal clinical contact |
Primary outcome
Reduction in alcohol use
Time frame: 8 weeks
1 secondary outcome
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
Time frame: 8 weeks
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 9 Mar 2020.
- Derived from this study: PubMed 27488212Kiluk BD, Devore KA, Buck MB, Nich C, Frankforter TL, LaPaglia DM, Yates BT, Gordon MA, Carroll KM. Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Alcohol Clin Exp Res. 2016 Sep;40(9):1991-2000. doi: 10.1111/acer.13162. Epub 2016 Aug 4.
Related trials for Alcohol Abuse or Dependence
Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
Alcohol Use Disorder, Alcoholism
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Abuse/Dependence
RecruitingPhase 2
Ketamine and Neurofeedback as Combined Therapeutic Interventions to Target Glutamatergic Neurotransmission in Alcohol Use Disorder
Alcohol Abuse/Dependence, Alcohol Use Disorder (AUD)
RecruitingPhase 2
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
Alcohol Use Disorder, Alcohol Dependence
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.
Kathleen Carroll, 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 Standard Treatment as Usual (TAU), Web-based CBT4CBT for alcohol plus TAU and Web-based CBT with minimal clinical contact in people with Alcohol Abuse or Dependence, 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 7 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 9 Mar 2020. 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?
Reduction in alcohol use (time frame: 8 weeks). 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 NCT01615497, 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 9 Mar 2020; AzTrials last refreshed its copy on 29 Oct 2026.