Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4, Canada
NCT Number: NCT05722483
This single-arm pilot study will recruit participants with moderate to severe alcohol use disorder for a 4-week virtual intensive outpatient program (IOP). The program aims to replicate the structure and abstinence monitoring of a residential treatment program although the program is delivered entirely virtually.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M6J 1H4, Canada
This pragmatic single-arm pilot study will recruit participants with moderate to severe alcohol use disorder who are seeking abstinence for a virtual intensive outpatient program (virtual IOP) The IOP will take place primarily over a 4 week period. Components of the program include a cognitive behavioral therapy for alcohol use disorder group (12 sessions), a DBT skills group (12 sessions), a Health and Wellness group (8 sessions), weekly individual therapy, weekly medication management appointments, and abstinence monitoring multiple times per day using breathalyzers equipped with facial recognition and internet connectivity. Following completion of the program, participants will complete an on-site end of treatment visit and two follow up visits at approximately day 30 and day 60 following termination of the virtual IOP. Participants will be offered the opportunity to participate in an optional weekly aftercare group for approximately 2 months after completion of the virtual IOP. Interested participants will also be able to complete optional follow-up sessions every 2 months for an additional 10 months following the end of the 60-day follow-up session.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Components of the intervention include a cognitive behavioral therapy for alcohol use disorder group (12 sessions), a DBT skills group (12 sessions), a Health and Wellness group (8 sessions), weekly individual therapy, weekly medication management appointments, and abstinence monitoring multiple times per day using breathalyzers equipped with facial recognition and internet connectivity.
Time frame: 28 Days
Proportion of study participants that complete the entire IOP. Dropouts will include (1) individuals who miss two of the first three days of group therapy or (2) individuals who miss > 5 total days of group therapy (i.e. over 25% of the program) or (3) Participants who do not complete their breathalyzer monitoring for over 25% of the study (e.g., miss readings on > 7 days, with some exceptions). Our target retention rate to demonstrate feasibility is ≥ 50% of participants (participants who do not show up to any groups will not be included in this or other analyses).
Time frame: 28 days
Measures overall satisfaction with the treatment program (minimum score = 8; maximum score = 32; higher score indicates greater client satisfaction). Client satisfaction ratings in the good to excellent range (20-32) will be considered as strong evidence of acceptable levels of satisfaction with the intervention. This will be our primary measure of client satisfaction.
Time frame: 28 days
Measures satisfaction with the telehealth platform and service delivery over telehealth (minimum score = 12; maximum score = 48; higher score indicates greater satisfaction with the telemedicine platform).
Time frame: 28 days
Number of days in which individuals did not consume any alcohol.
Time frame: 28 days
Number of binge drinking days (4+ drinks for females, 5+ drinks for males)
Time frame: 28 days
Average Drinks Per Day
Time frame: 28 days
Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving.
Time frame: 28 days
Measures quality of life (scores are transformed to 0-100; higher scores indicate higher quality of life).
Time frame: 28 days
Measures depressive symptoms (minimum score = 0; maximum score = 27; higher scores indicate higher levels of depressive symptoms).
Time frame: 28 days
Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)
Time frame: 28 days
Measures quality of sleep (minimum score = 0; maximum score = 21; higher scores indicate lower quality of sleep).
Time frame: 28 days
Measures difficulties in emotion regulation (minimum score = 36; maximum score = 180; higher scores indicate more difficulties in emotion regulation)
Time frame: 28 days
Measures cognitive reappraisal (minimum score = 6; maximum score = 42; higher score indicates more frequent use of reappraisal) and expressive suppression (minimum score = 4; maximum score = 28; higher scores indicate more frequent use of suppression).
Centre for Addiction and Mental Health
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04523922
Alcohol Use Disorder, Alcohol-Related Disorders
Charleston, South Carolina, United States
View Trial DetailsNCT06817356
Alcohol Use Disorder, Alcohol-Related Disorders
Scottsdale, Arizona, United States
View Trial DetailsNCT05630118
Alcohol Use Disorder, Alcohol-Related Disorders
Lexington, Kentucky, United States
View Trial DetailsNCT06545929
Alcohol Use Disorder, Alcohol-Related Disorders
Columbus, Ohio, United States
View Trial Details