Computer Based Training in CBT in Primary Care
2 other identifiers
interventional
58
1 country
1
Brief Summary
To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedSeptember 12, 2018
September 1, 2018
1.8 years
January 4, 2017
September 11, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
retention in treatment
subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
0 - 8 weeks
reduction in drug use
Using urine and breathalyzer screening for negative drug and alcohol testing
0 - 8 weeks
Study Arms (2)
Standard treatment as usual (TAU)
NO INTERVENTIONTreatment normally offered at this primary care clinic
TAU plus CBT4CBT program
ACTIVE COMPARATORTreatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.
Interventions
Treatment normally offered at this primary care clinic
Eligibility Criteria
You may qualify if:
- Are 18 years of age or older.
- Are applying for outpatient substance abuse treatment
- Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
- 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.
You may not qualify if:
- Have an untreated bipolar or schizophrenic disorder
- Have a current legal case pending such that incarceration during the 8 week protocol is likely
- Are in need of detoxification from alcohol, opioids or benzodiazepines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (1)
Yale New Haven Hospital St Raphael's Campus
New Haven, Connecticut, 06604, United States
Related Publications (1)
Tetrault JM, Holt SR, Cavallo DA, O'Connor PG, Gordon MA, Corvino JK, Nich C, Carroll KM. Computerized Cognitive Behavioral Therapy for Substance Use Disorders in a Specialized Primary Care Practice: A Randomized Feasibility Trial to Address the RT Component of SBIRT. J Addict Med. 2020 Dec;14(6):e303-e309. doi: 10.1097/ADM.0000000000000663.
PMID: 32371660DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen M Carroll, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 6, 2017
Study Start
November 1, 2016
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
September 12, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share