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Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Virtual Intensive Outpatient Program
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol Use Disorder, Telemedicine, Cognitive Behavioral Therapy, Dialectical Behavior Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 18 years of age Able to communicate and provide informed consent in English Diagnosis of moderate to severe AUD, based on the Structured Clinical Interview for DSM-5, Research Version (SCID-5-RV) 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. Motivated to abstain from alcohol for the month-long treatment period (longer-term harm reduction goals are permitted) Access to a private location from which to participate in the program for the duration of the study. 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. Enrolled in the Ontario Health Insurance Plan (OHIP) Exclusion Criteria: Severe medical or psychiatric comorbidity that would prevent safe participation in the study Active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month. 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) History of alcohol withdrawal delirium Currently pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study. Enrollment in another study that conflicts with the procedures or scientific integrity of this study Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual Intensive Outpatient Program

Arm Description

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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.
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)
Changes in Average Drinks Per Day During the IOP Assessed by the Timeline Followback Interview (TLFB)
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.
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).
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).
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)
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).
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)
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).

Full Information

First Posted
January 13, 2023
Last Updated
May 2, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05722483
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Alcohol Use Disorder, Telemedicine, Cognitive Behavioral Therapy, Dialectical Behavior Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age Able to communicate and provide informed consent in English Diagnosis of moderate to severe AUD, based on the Structured Clinical Interview for DSM-5, Research Version (SCID-5-RV) 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. Motivated to abstain from alcohol for the month-long treatment period (longer-term harm reduction goals are permitted) Access to a private location from which to participate in the program for the duration of the study. 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. Enrolled in the Ontario Health Insurance Plan (OHIP) Exclusion Criteria: Severe medical or psychiatric comorbidity that would prevent safe participation in the study Active and severe suicidal ideation at time of eligibility assessment or suicide attempt within the past month. 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) History of alcohol withdrawal delirium Currently pregnant, breastfeeding, or intending to become pregnant or breastfeed during the study. Enrollment in another study that conflicts with the procedures or scientific integrity of this study Individuals planning to be out of the province during the virtual intensive outpatient program will not be permitted to enroll.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Xiao, BSc
Phone
416-535-8501
Ext
32447
Email
Kelly.Xiao@camh.ca
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Xiao, BSc
Phone
416-535-8501
Ext
32447
First Name & Middle Initial & Last Name & Degree
Matthew Sloan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intensive Virtual Treatment With Remote Abstinence Monitoring for Alcohol Use Disorder

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