Clinical trial NCT05722483: Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder
Official title: Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol Use Disorder
Telemedicine
Cognitive Behavioral Therapy
Dialectical Behavior Therapy
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-02-10
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Able to communicate and provide informed consent in English
3. Diagnosis of moderate to severe AUD, based on the Structured Clinical Interview for DSM-5, Research Version (SCID-5-RV)
4. Risky alcohol consumption, defined as \> 10 drinks per week for females and \> 15 drinks for males on average during the 60 days prior to the eligibility assessment.
5. Motivated to abstain from alcohol for the month-long treatment period (longer-term harm reduction goals are permitted)
6. Access to a private location from which to participate in the program for the duration of the study.
7. Able and motivated to complete all aspects of the program, including attending all virtual intensive outpatient program sessions (this includes being available for group and individual sessions throughout the day on weekdays) and completing multiple daily breathalyzer readings throughout the entire program. Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.
8. Enrolled in the Ontario Health Insurance Plan (OHIP)

Exclusion Criteria:

1. Severe medical or psychiatric comorbidity that would prevent safe participation in the study
2. Active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month.
3. Diagnosis of opioid use disorder or sedative use disorder within the past year based on the SCID-5 (other concurrent substance use disorders such as cannabis use disorder will not be exclusionary)
4. History of alcohol withdrawal delirium
5. Currently pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study.
6. Enrollment in another study that conflicts with the procedures or scientific integrity of this study
7. Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.

Primary outcomes:
measure: Retention in treatment
timeFrame: 28 Days
measure: Satisfaction with treatment as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 28 days
Secondary outcomes:
measure: Satisfaction with Telemedicine Delivery as Assessed by a modified version of the Telehealth Satisfaction Scale (TESS)
timeFrame: 28 days
measure: Changes in Number of Abstinence Days During the IOP Assessed by the Timeline Followback Interview (TLFB)
timeFrame: 28 days
measure: Changes in Number of Binge Drinking Days During the IOP Assessed by the Timeline Followback Interview (TLFB)
timeFrame: 28 days
measure: Changes in Average Drinks Per Day During the IOP Assessed by the Timeline Followback Interview (TLFB)
timeFrame: 28 days
measure: Change in Self-Reported Alcohol Craving During the IOP Assessed by the Penn Alcohol Craving Scale (PACS)
timeFrame: 28 days
measure: Change in Quality of Life during the IOP Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: 28 days
measure: Change in Depressive Symptoms during the IOP Assessed Using the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 28 days
measure: Change in Anxiety Symptoms during the IOP Assessed Using the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 28 days
measure: Change in Sleep during the IOP Assessed Using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 28 days
measure: Change in Emotion Regulation During the IOP Assessed Using the Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 28 days
measure: Change in Emotion Regulation During the IOP Assessed Using the Emotion Regulation Questionnaire (ERQ)
timeFrame: 28 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Matthew Sloan, MD
role: PRINCIPAL_INVESTIGATOR
References: