An interventional study of PAHOLA (digital health assistant) and Standard information on alcohol use and health in Alcohol Drinking and Alcoholism, sponsored by Centre for Addiction and Mental Health. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
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:
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.
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.
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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.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
Browse Alcohol Drinking studies →Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Participants will interact with PAHOLA the digital assistant of the Pan American Health Organization.
Other: PAHOLA (digital health assistant)
Participants will interact with PAHOLA (text only version) the digital assistant of the Pan American Health Organization.
Other: PAHOLA (digital health assistant)
A PDF containing standard information on alcohol use and risk from the Pan American Health Organization.
Other: Standard information on alcohol use and health
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.
A brochure on alcohol use and health as produced by the Pan American Health Organization will be provided to participants.
Changes in alcohol use quantity
Alcohol use quantity (measured in average grams per day in the past week)
Time frame: 1 month
Changes in alcohol use quantity
Alcohol use quantity (measured in average grams per day in the past week)
Time frame: 3 months
Changes in alcohol use quantity
Alcohol use quantity (measured in average grams per day in the past week)
Time frame: 6 months
Changes in alcohol use frequency
Alcohol use frequency (measured in drinking days in the past week)
Time frame: 1 month
Changes in alcohol use frequency
Alcohol use frequency (measured in drinking days in the past week)
Time frame: 3 months
Changes in alcohol use frequency
Alcohol use frequency (measured in drinking days in the past week)
Time frame: 6 months
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.
Time frame: 1 month
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.
Time frame: 3 months
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.
Time frame: 6 months
Changes in anxiety
Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
Time frame: 1 months
Changes in anxiety
Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
Time frame: 3 months
Changes in anxiety
Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
Time frame: 6 months
Changes in depression
Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
Time frame: 1 months
Changes in depression
Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
Time frame: 3 months
Changes in depression
Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
Time frame: 6 months
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.
Time frame: 1 month
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.
Time frame: 3 months
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.
Time frame: 6 months
Packs of cigarettes smoked in the past week
Packs of cigarettes smoked in the past week
Time frame: 1 month
Packs of cigarettes smoked in the past week
Packs of cigarettes smoked in the past week
Time frame: 3 months
Packs of cigarettes smoked in the past week
Packs of cigarettes smoked in the past week
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre for Addiction and Mental Health