Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title:

Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722483
• Other study ID #: 055/2022
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Centre for Addiction and Mental Health
• Contact: Kelly Xiao, MSc
• Phone: 416-535-8501
• Email: Kelly.Xiao[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Other:
• Virtual Intensive Outpatient Program
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.

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in treatment	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).	28 Days
Primary	Satisfaction with treatment as assessed by the Client Satisfaction Questionnaire-8 (CSQ-8)	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.	28 days
Secondary	Satisfaction with Telemedicine Delivery as Assessed by a modified version of the Telehealth Satisfaction Scale (TESS)	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).	28 days
Secondary	Changes in Number of Abstinence Days During the IOP Assessed by the Timeline Followback Interview (TLFB)	Number of days in which individuals did not consume any alcohol.	28 days
Secondary	Changes in Number of Binge Drinking Days During the IOP Assessed by the Timeline Followback Interview (TLFB)	Number of binge drinking days (4+ drinks for females, 5+ drinks for males)	28 days
Secondary	Changes in Average Drinks Per Day During the IOP Assessed by the Timeline Followback Interview (TLFB)	Average Drinks Per Day	28 days
Secondary	Change in Self-Reported Alcohol Craving During the IOP Assessed by the Penn Alcohol Craving Scale (PACS)	Measures craving for alcohol (minimum score = 0; maximum score = 30; higher score indicates greater levels of craving.	28 days
Secondary	Change in Quality of Life during the IOP Assessed Using the Abbreviated World Health Organization Quality of Life Scale (WHOQOL-BREF)	Measures quality of life (scores are transformed to 0-100; higher scores indicate higher quality of life).	28 days
Secondary	Change in Depressive Symptoms during the IOP Assessed Using the Patient Health Questionnaire-9 (PHQ-9)	Measures depressive symptoms (minimum score = 0; maximum score = 27; higher scores indicate higher levels of depressive symptoms).	28 days
Secondary	Change in Anxiety Symptoms during the IOP Assessed Using the Generalized Anxiety Disorder-7 (GAD-7)	Measures generalized anxiety (Minimum score = 0; maximum score = 21; higher scores indicate higher levels of anxiety)	28 days
Secondary	Change in Sleep during the IOP Assessed Using the Pittsburgh Sleep Quality Index (PSQI)	Measures quality of sleep (minimum score = 0; maximum score = 21; higher scores indicate lower quality of sleep).	28 days
Secondary	Change in Emotion Regulation During the IOP Assessed Using the Difficulties in Emotion Regulation Scale (DERS)	Measures difficulties in emotion regulation (minimum score = 36; maximum score = 180; higher scores indicate more difficulties in emotion regulation)	28 days
Secondary	Change in Emotion Regulation During the IOP Assessed Using the Emotion Regulation Questionnaire (ERQ)	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).	28 days