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Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project

Primary Purpose

Alcohol Drinking, Alcoholism

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PAHOLA (digital health assistant)
Standard information on alcohol use and health
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 Drinking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Current drinkers 18 years of age and older who score 7 to 23 on the Alcohol Use Disorders Identification Test Use of medication to treat harmful alcohol use will be allowed provided that the dose has been stable for 8 weeks Availability of a computer with a connection to the internet and a camera and microphone Exclusion Criteria: A history of drug use disorders (other than alcohol) in the last two years (except tobacco use disorder) Dose changes of concomitant medications will not be permitted during the study period Pregnant or lactating women, and women of childbearing potential who are not using medically accepted forms of contraception, or women who are planning on becoming pregnant during the study time frame People who are currently reciving psychological treatment for alcohol use disorders

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Digital intervention

    Digital intervention (text only)

    Information on alcohol use and risk

    Arm Description

    Participants will interact with PAHOLA the digital assistant of the Pan American Health Organization.

    Participants will interact with PAHOLA (text only version) the digital assistant of the Pan American Health Organization.

    A PDF containing standard information on alcohol use and risk from the Pan American Health Organization.

    Outcomes

    Primary Outcome Measures

    Changes in alcohol use quantity
    Alcohol use quantity (measured in average grams per day in the past week)
    Changes in alcohol use quantity
    Alcohol use quantity (measured in average grams per day in the past week)
    Changes in alcohol use quantity
    Alcohol use quantity (measured in average grams per day in the past week)
    Changes in alcohol use frequency
    Alcohol use frequency (measured in drinking days in the past week)
    Changes in alcohol use frequency
    Alcohol use frequency (measured in drinking days in the past week)
    Changes in alcohol use frequency
    Alcohol use frequency (measured in drinking days in the past week)
    Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
    Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
    Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
    Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
    Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
    Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.

    Secondary Outcome Measures

    Changes in anxiety
    Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
    Changes in anxiety
    Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
    Changes in anxiety
    Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
    Changes in depression
    Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
    Changes in depression
    Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
    Changes in depression
    Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
    Changes in quality of life
    Short Form Health Survey-12 item (SF-12); Scale range: 0 to 100; Higher scores indicating better physical and mental health functioning.
    Changes in quality of life
    Short Form Health Survey-12 item (SF-12); Scale range: 0 to 100; Higher scores indicating better physical and mental health functioning.
    Changes in quality of life
    Short Form Health Survey-12 item (SF-12); Scale range: 0 to 100; Higher scores indicating better physical and mental health functioning.
    Packs of cigarettes smoked in the past week
    Packs of cigarettes smoked in the past week
    Packs of cigarettes smoked in the past week
    Packs of cigarettes smoked in the past week
    Packs of cigarettes smoked in the past week
    Packs of cigarettes smoked in the past week

    Full Information

    First Posted
    May 29, 2023
    Last Updated
    September 12, 2023
    Sponsor
    Centre for Addiction and Mental Health
    Collaborators
    Canadian Institutes of Health Research (CIHR), Pan American Health Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05906979
    Brief Title
    Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project
    Official Title
    Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    Alcohol use disorders are among the most prevalent mental disorders in Canada; however, due to numerous barriers, including fear of treatment, privacy concerns, stigma, time conflicts, and lack of availability of treatment, less than 10% of people with alcohol dependence receive treatment. Accordingly, there is a need to expand treatment coverage for alcohol use disorders, especially for populations which face barriers to receiving treatment. The objective of this proposed project is to develop a digital health worker, named PAHOLA, which can effectively deliver interventions to people who would not otherwise receive such treatment. To achieve this objective, the following research aims will be addressed: To develop a digital human-based intervention that can initiate change processes and reduce alcohol use by applying the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT) in a credible manner. To assess the impact of the virtual care provided by PAHOLA on health outcomes using a randomized controlled study design (RCT) to assess potential effect sizes for a larger future RCT. If successful, the PAHOLA project has the potential to transform our ability to prevent alcohol-attributable harms in Canada by promoting health, health equity, and well-being, especially among those people who do not normally receive treatment for harmful alcohol use.
    Detailed Description
    Alcohol use disorders are among the most prevalent mental disorders in Canada; however, due to numerous barriers, including fear of treatment, privacy concerns, stigma, time conflicts, and lack of availability of treatment, less than 10% of people with alcohol dependence receive treatment. Accordingly, there is a need to expand treatment coverage for alcohol use disorders, especially for populations which face barriers to receiving treatment. . The objective of this proposed project is to tailor PAHOLA into a digital health worker which can effectively deliver BIs to people who would not otherwise receive such treatment. To achieve this objective, the following research aims will be addressed: 3. To develop a digital human-based intervention that can initiate change processes and reduce alcohol use by applying the principles of motivational interviewing (MI) and cognitive behavioural therapy (CBT) in a credible manner. 4. To assess the impact of the virtual care provided by PAHOLA on health outcomes using a randomized controlled study design (RCT) to assess potential effect sizes for a larger future RCT. To address these objectives, the study will employ the following research strategy This project will build upon the PAHOLA digital human prototype which was developed by Soul Machines, the Pan American Health Organization (PAHO), and Rooftop to provide information on alcohol risks and harms. This project will develop PAHOLA to intervene in cases of hazardous and harmful alcohol use, and will take place in the following three phases: Phase 1 - development of the intervention dialogue flow program. PAHOLA will (i) screen for harmful alcohol use using the AUDIT, and (ii) deliver Brief Intervention (BIs). The BIs will be based primarily on two evidence-based approaches that are used to effectively treat alcohol misuse, namely MI and CBT. Dialogue will be constructed in alignment with FRAMES - Feedback, Responsibility, Advice, Menu of options, Empathy, and Self efficacy (confidence for change),and OARS - (Open ended questions, Affirmation, Reflective listening, and Summarizing). Phase 2 - a two-day virtual meeting of researchers, health care providers, and people with lived experience. A virtual meeting of a total of 30 experts will be held to comment upon and further develop PAHOLA. Meeting participants will formulate a series of evidence-based recommendations regarding how to improve: 1) the affinity and trustworthiness of PAHOLA, 2) the dialogue flow for BIs, and 3) the specific dialogue flows for men and women. Phase 3 - a pilot randomized controlled trial (RCT) of the PAHOLA intervention program. To assess PAHOLA as a potential intervention for treating harmful alcohol use, a pilot RCT will be performed where the first group will receive a BI, the second group will receive a text-only version of PAHO's BI, and the third group will receive information from PAHOLA about the risks of alcohol use. A total of 180 adults (18 years of age and older) with hazardous and harmful alcohol use will be recruited via online advertisements and databases of individuals interested in participating in research studies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking, Alcoholism

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Model Description
    a pilot RCT will be performed where the first group will receive a BI, the second group will receive a text-only version of PAHO's BI, and the third group will receive information from PAHOLA about the risks of alcohol use.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Digital intervention
    Arm Type
    Experimental
    Arm Description
    Participants will interact with PAHOLA the digital assistant of the Pan American Health Organization.
    Arm Title
    Digital intervention (text only)
    Arm Type
    Experimental
    Arm Description
    Participants will interact with PAHOLA (text only version) the digital assistant of the Pan American Health Organization.
    Arm Title
    Information on alcohol use and risk
    Arm Type
    Other
    Arm Description
    A PDF containing standard information on alcohol use and risk from the Pan American Health Organization.
    Intervention Type
    Other
    Intervention Name(s)
    PAHOLA (digital health assistant)
    Intervention Description
    Pahola is the Pan American Health Organization's new digital health specialist on alcohol use. Programmed with the latest information and research, she can help you make healthier decisions related to your alcohol consumption. Pahola is free to use and can easily be accessed from the privacy of your own home by making use of the online app.
    Intervention Type
    Other
    Intervention Name(s)
    Standard information on alcohol use and health
    Intervention Description
    A brochure on alcohol use and health as produced by the Pan American Health Organization will be provided to participants.
    Primary Outcome Measure Information:
    Title
    Changes in alcohol use quantity
    Description
    Alcohol use quantity (measured in average grams per day in the past week)
    Time Frame
    1 month
    Title
    Changes in alcohol use quantity
    Description
    Alcohol use quantity (measured in average grams per day in the past week)
    Time Frame
    3 months
    Title
    Changes in alcohol use quantity
    Description
    Alcohol use quantity (measured in average grams per day in the past week)
    Time Frame
    6 months
    Title
    Changes in alcohol use frequency
    Description
    Alcohol use frequency (measured in drinking days in the past week)
    Time Frame
    1 month
    Title
    Changes in alcohol use frequency
    Description
    Alcohol use frequency (measured in drinking days in the past week)
    Time Frame
    3 months
    Title
    Changes in alcohol use frequency
    Description
    Alcohol use frequency (measured in drinking days in the past week)
    Time Frame
    6 months
    Title
    Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
    Description
    Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
    Time Frame
    1 month
    Title
    Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
    Description
    Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
    Time Frame
    3 months
    Title
    Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
    Description
    Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Changes in anxiety
    Description
    Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
    Time Frame
    1 months
    Title
    Changes in anxiety
    Description
    Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
    Time Frame
    3 months
    Title
    Changes in anxiety
    Description
    Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
    Time Frame
    6 months
    Title
    Changes in depression
    Description
    Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
    Time Frame
    1 months
    Title
    Changes in depression
    Description
    Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
    Time Frame
    3 months
    Title
    Changes in depression
    Description
    Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
    Time Frame
    6 months
    Title
    Changes in quality of life
    Description
    Short Form Health Survey-12 item (SF-12); Scale range: 0 to 100; Higher scores indicating better physical and mental health functioning.
    Time Frame
    1 month
    Title
    Changes in quality of life
    Description
    Short Form Health Survey-12 item (SF-12); Scale range: 0 to 100; Higher scores indicating better physical and mental health functioning.
    Time Frame
    3 months
    Title
    Changes in quality of life
    Description
    Short Form Health Survey-12 item (SF-12); Scale range: 0 to 100; Higher scores indicating better physical and mental health functioning.
    Time Frame
    6 months
    Title
    Packs of cigarettes smoked in the past week
    Description
    Packs of cigarettes smoked in the past week
    Time Frame
    1 month
    Title
    Packs of cigarettes smoked in the past week
    Description
    Packs of cigarettes smoked in the past week
    Time Frame
    3 months
    Title
    Packs of cigarettes smoked in the past week
    Description
    Packs of cigarettes smoked in the past week
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Current drinkers 18 years of age and older who score 7 to 23 on the Alcohol Use Disorders Identification Test Use of medication to treat harmful alcohol use will be allowed provided that the dose has been stable for 8 weeks Availability of a computer with a connection to the internet and a camera and microphone Exclusion Criteria: A history of drug use disorders (other than alcohol) in the last two years (except tobacco use disorder) Dose changes of concomitant medications will not be permitted during the study period Pregnant or lactating women, and women of childbearing potential who are not using medically accepted forms of contraception, or women who are planning on becoming pregnant during the study time frame People who are currently reciving psychological treatment for alcohol use disorders
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kevin Shield
    Phone
    416-535-8501
    Ext
    36768
    Email
    kevin.shield@camh.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kevin Shield
    Organizational Affiliation
    Centre for Addiction and Mental Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project

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