Substance-Related DisordersPhase 1NCT01406899
Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)
A Phase 1 study testing Computer Based Treatment in people with Substance-Related Disorders, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Computer Based Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2013
- Phase
- Phase 1
- 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
- 18 years and older
- Recent (within 3 months) substance use
- meet current DSM-IV (Diagnostic and Statistical Manual-IV) criteria for substance use disorder
- fluent in English or at least a 6th grade reading level
- can commit to at least 8 weeks of treatment and willing to be randomized to treatment
Who cannot join
- Unstable housing situation
- Likelihood of going to prison during the intervention portion of study
- Recent opiate or benzodiazepine prescription
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut VA Healthcare System
Newington, Connecticut, 06111
About this study
Official title: Computer-Assisted Cognitive Behavior Therapy for Veterans With Substance Use Disorder
In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.
Read the detailed description
This pilot study aims to evaluate the feasibility and effectiveness of adding a computer based training program in Cognitive Behavior Therapy ("CBT4CBT") for the treatment of addictions in a VA substance abuse outpatient clinic. Key secondary aims are to assess the impact of adding CBT4CBT to standard care on treatment attendance, engagement, retention, and to investigate if certain process measures are associated with substance use outcomes. Approximately 80 patients enrolled in the Newington Outpatient Substance Abuse Treatment Program (SATP) will be randomly assigned to either (A) treatment as usual, or (B) treatment as usual plus exposure to the CBT4CBT program.
- Conditions
- Substance-Related Disorders
- Being tested
- Computer Based Treatment
- 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.
Computer Based TreatmentBehavioural
Also called Cognitive Behavioral Therapy
Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as Usual | No intervention | Standard treatment as usual (TAU) in the VA Connecticut Healthcare System substance abuse clinic consisting of individual and group therapy sessions and regular urine monitoring. |
| Computer-based treatment | Experimental | Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks. Receives: Behavioral: Computer Based Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in substance use
percent days abstinent, confirmed by urine toxicology screens
Measured: 8 weeks
Secondary outcomes (1)
Retention in treatment
did patient continued to be enrolled in substance abuse treatment at follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionMay 2013
- Study completionDec 2013
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 Substance-Related DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathleen Carroll, Ph.D., Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406899
- Sponsor's protocol ID
- JC0008
- Status last verified
- Mar 2012
- First submitted
- 27 Jul 2011
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lichenstein SD, Kohler R, Ye F, Potenza MN, Kiluk B, Yip SW. Distinct neural networks predict cocaine versus cannabis treatment outcomes. Mol Psychiatry. 2023 Aug;28(8):3365-3372. doi: 10.1038/s41380-023-02120-0. Epub 2023 Jun 12.
PubMed 37308679
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Assisted Cognitive Behavior Therapy for Veterans With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT01406899
- Acronym / sponsor ID
- JC0008
- Conditions
- Substance-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jan 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 1 Aug 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.
In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.
Detailed description
This pilot study aims to evaluate the feasibility and effectiveness of adding a computer based training program in Cognitive Behavior Therapy ("CBT4CBT") for the treatment of addictions in a VA substance abuse outpatient clinic. Key secondary aims are to assess the impact of adding CBT4CBT to standard care on treatment attendance, engagement, retention, and to investigate if certain process measures are associated with substance use outcomes. Approximately 80 patients enrolled in the Newington Outpatient Substance Abuse Treatment Program (SATP) will be randomly assigned to either (A) treatment as usual, or (B) treatment as usual plus exposure to the CBT4CBT program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as Usual | No intervention | –Standard treatment as usual (TAU) in the VA Connecticut Healthcare System substance abuse clinic consisting of individual and group therapy sessions and regular urine monitoring. |
| Computer-based treatment | Experimental | Behavioral: Computer Based TreatmentStandard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older
- Recent (within 3 months) substance use
- meet current DSM-IV (Diagnostic and Statistical Manual-IV) criteria for substance use disorder
- fluent in English or at least a 6th grade reading level
- can commit to at least 8 weeks of treatment and willing to be randomized to treatment
Key exclusion criteria (3 listed)
- Unstable housing situation
- Likelihood of going to prison during the intervention portion of study
- Recent opiate or benzodiazepine prescription
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 |
|---|---|---|
| Computer Based TreatmentAlso: Cognitive Behavioral TherapyStandard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks. | Behavioural | Computer-based treatment |
Primary outcome
Reduction in substance use
Time frame: 8 weeks
percent days abstinent, confirmed by urine toxicology screens
1 secondary outcome
Retention in treatment
Time frame: 6 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 23 Dec 2014.
- Derived from this study: PubMed 37308679Lichenstein SD, Kohler R, Ye F, Potenza MN, Kiluk B, Yip SW. Distinct neural networks predict cocaine versus cannabis treatment outcomes. Mol Psychiatry. 2023 Aug;28(8):3365-3372. doi: 10.1038/s41380-023-02120-0. Epub 2023 Jun 12.
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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, Ph.D. study director
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 study testing Computer Based Treatment in people with Substance-Related Disorders, run by VA Connecticut Healthcare System 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 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 23 Dec 2014. 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 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.
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 substance 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 NCT01406899, 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 23 Dec 2014; AzTrials last refreshed its copy on 29 Oct 2026.