Substance AbusePhase 1/2Man VS MachineNCT01442597
Computer Based Training in Cognitive Behavioral Therapy Web-based
A Phase 1/2 study testing Standard Treatment As Usual (TAU), Individual clinician-provided CBT and CBT4CBT in people with Substance Abuse, run by Yale University at 1 site in United States.
Trial summary
The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling at SATU. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Standard Treatment As Usual (TAU), 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
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2018
- Phase
- Phase 1/2
- 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 65 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 cocaine, marijuana,opioid,or amphetamine dependence.
- Are sufficiently stable for 12 weeks of outpatient treatment.
- Can commit to 12 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 12-week protocol is likely.
- Are physically dependent on alcohol, opioids or benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Abuse Treatment Unit (SATU)
New Haven, Connecticut, 06510
About this study
The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling at 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
One hundred eighty drug-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) individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). 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
- Substance Abuse
- Being tested
- Standard Treatment As Usual (TAU), Individual clinician-provided CBT, CBT4CBT
- Keywords
- cognitive behavior therapy, computer assisted instruction, drug abuse therapy, educational resource design and development
- Medical subject headings
- Substance-Related Disorders
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 drug counseling sessions one time per week last one hour each time.
Individual clinician-provided CBTBehavioural
Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.
CBT4CBTBehavioural
Subjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session.
| Study group | Role | What they receive |
|---|---|---|
| Individual clinician-provided CBT | Active comparator | Individual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program. Receives: Behavioral: Individual clinician-provided CBT |
| CBT4CBT | Experimental | A computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. Receives: Behavioral: CBT4CBT |
| 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 substance abuse. Receives: Behavioral: Standard Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in drug abuse
Measured: 12 weeks
Secondary outcomes (1)
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen Carroll, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442597
- Sponsor's protocol ID
- 1004006632
- Other IDs
- 2P50DA009241-21
- Acronym
- Man VS Machine
- Status last verified
- Mar 2020
- First submitted
- 26 Sep 2011
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schick MR, Jaramillo Y, Kiluk BD, Nich C, LaPaglia D, Haeny AM. Testing measurement invariance of the Brief Symptom Inventory across race, sex, and time among adults with cocaine use disorder. Psychol Assess. 2026 Jul 9:10.1037/pas0001486. doi: 10.1037/pas0001486. Online ahead of print.
PubMed 42423707Kiluk BD, Nich C, Buck MB, Devore KA, Frankforter TL, LaPaglia DM, Muvvala SB, Carroll KM. Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Am J Psychiatry. 2018 Sep 1;175(9):853-863. doi: 10.1176/appi.ajp.2018.17090978. Epub 2018 May 24.
PubMed 29792052
Study at a glance
From the registry record, last updated by the sponsor on 6 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
- ClinicalTrials.gov ID
- NCT01442597
- Acronym / sponsor ID
- Man VS Machine / 1004006632
- Conditions
- Substance Abuse
- Keywords
- cognitive behavior therapy, computer assisted instruction, drug abuse therapy, educational resource design and development
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 28 Sep 2011 (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 program to evaluate its effectiveness relative to standard outpatient counseling at 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
One hundred eighty drug-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) individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). 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 |
|---|---|---|
| Individual clinician-provided CBT | Active comparator | Behavioral: Individual clinician-provided CBTIndividual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program. |
| CBT4CBT | Experimental | Behavioral: CBT4CBTA computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. |
| 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 substance abuse. |
Who may qualify
- Ages
- 18 to 65 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 cocaine, marijuana,opioid,or amphetamine dependence.
- Are sufficiently stable for 12 weeks of outpatient treatment.
- Can commit to 12 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 12-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 drug counseling sessions one time per week last one hour each time. | Behavioural | Standard Treatment as Usual (TAU) |
| Individual clinician-provided CBTIndividual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session. | Behavioural | Individual clinician-provided CBT |
| CBT4CBTSubjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. | Behavioural | CBT4CBT |
Primary outcome
Reduction in drug abuse
Time frame: 12 weeks
1 secondary outcome
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation
Time frame: 12 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 6 Mar 2020.
- Derived from this study: PubMed 42423707Schick MR, Jaramillo Y, Kiluk BD, Nich C, LaPaglia D, Haeny AM. Testing measurement invariance of the Brief Symptom Inventory across race, sex, and time among adults with cocaine use disorder. Psychol Assess. 2026 Jul 9:10.1037/pas0001486. doi: 10.1037/pas0001486. Online ahead of print.
- Derived from this study: PubMed 29792052Kiluk BD, Nich C, Buck MB, Devore KA, Frankforter TL, LaPaglia DM, Muvvala SB, Carroll KM. Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Am J Psychiatry. 2018 Sep 1;175(9):853-863. doi: 10.1176/appi.ajp.2018.17090978. Epub 2018 May 24.
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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.
Kathleen Carroll, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Standard Treatment As Usual (TAU), Individual clinician-provided CBT and CBT4CBT in people with Substance Abuse, run by Yale University 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 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 6 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 drug abuse (time frame: 12 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 NCT01442597, which also lists 2 linked publications.
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 6 Mar 2020.