Alcohol DrinkingNCT05906979
Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project
A study testing PAHOLA (digital health assistant) and Standard information on alcohol use and health in people with Alcohol Drinking and Alcoholism, run by Centre for Addiction and Mental Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcoholism
- What is being tested?
- PAHOLA (digital health assistant) and Standard information on alcohol use and health
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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:
Read more
- 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.
Read the 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:
- 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.
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.
- Conditions
- Alcohol Drinking, Alcoholism
- Being tested
- PAHOLA (digital health assistant), Standard information on alcohol use and health
- Medical subject headings
- Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAHOLA (digital health assistant)Other
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.
Standard information on alcohol use and healthOther
A brochure on alcohol use and health as produced by the Pan American Health Organization will be provided to participants.
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention | Experimental | Participants will interact with PAHOLA the digital assistant of the Pan American Health Organization. Receives: Other: PAHOLA (digital health assistant) |
| Digital intervention (text only) | Experimental | Participants will interact with PAHOLA (text only version) the digital assistant of the Pan American Health Organization. Receives: Other: PAHOLA (digital health assistant) |
| Information on alcohol use and risk | Other | A PDF containing standard information on alcohol use and risk from the Pan American Health Organization. Receives: Other: Standard information on alcohol use and health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alcohol use quantity
Alcohol use quantity (measured in average grams per day in the past week)
Measured: 1 month
Changes in alcohol use quantity
Alcohol use quantity (measured in average grams per day in the past week)
Measured: 3 months
Changes in alcohol use quantity
Alcohol use quantity (measured in average grams per day in the past week)
Measured: 6 months
Changes in alcohol use frequency
Alcohol use frequency (measured in drinking days in the past week)
Measured: 1 month
Changes in alcohol use frequency
Alcohol use frequency (measured in drinking days in the past week)
Measured: 3 months
Changes in alcohol use frequency
Alcohol use frequency (measured in drinking days in the past week)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (12)
Changes in anxiety
Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
Measured: 1 months
Changes in anxiety
Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
Measured: 3 months
Changes in anxiety
Hamilton Anxiety Rating Scale (HAM-A) 36; Scale range: 0-56; Higher scores indicate worse anxiety
Measured: 6 months
Changes in depression
Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
Measured: 1 months
Changes in depression
Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
Measured: 3 months
Changes in depression
Patient Depression Questionnaire - 9 item version; Scale range: 0 to 27; Higher scores indicate worse depression
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Packs of cigarettes smoked in the past week
Packs of cigarettes smoked in the past week
Measured: 1 month
Packs of cigarettes smoked in the past week
Packs of cigarettes smoked in the past week
Measured: 3 months
Packs of cigarettes smoked in the past week
Packs of cigarettes smoked in the past week
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 May 2022 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Why it stopped: The tool to be evaluated is no longer provided by the WHO
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pan American Health Organization
- Responsible party
- Principal investigator, Jurgen Rehm, Centre for Addiction and Mental Health
- Investigators
- Kevin Shield, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906979
- Sponsor's protocol ID
- 2023-0615
- Status last verified
- Mar 2026
- First submitted
- 29 May 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Human-Based Brief Interventions for Harmful Alcohol Use: The PAHOLA Project
- ClinicalTrials.gov ID
- NCT05906979
- Acronym / sponsor ID
- 2023-0615
- Conditions
- Alcohol Drinking, Alcoholism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The tool to be evaluated is no longer provided by the WHO
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Pan American Health Organization
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital intervention | Experimental | Other: PAHOLA (digital health assistant)Participants will interact with PAHOLA the digital assistant of the Pan American Health Organization. |
| Digital intervention (text only) | Experimental | Other: PAHOLA (digital health assistant)Participants will interact with PAHOLA (text only version) the digital assistant of the Pan American Health Organization. |
| Information on alcohol use and risk | Other | Other: Standard information on alcohol use and healthA PDF containing standard information on alcohol use and risk from the Pan American Health Organization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAHOLA (digital health assistant)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. | Other | Digital intervention, Digital intervention (text only) |
| Standard information on alcohol use and healthA brochure on alcohol use and health as produced by the Pan American Health Organization will be provided to participants. | Other | Information on alcohol use and risk |
Primary outcome
Changes in alcohol use quantity
Time frame: 1 month
Alcohol use quantity (measured in average grams per day in the past week)
Changes in alcohol use quantity
Time frame: 3 months
Alcohol use quantity (measured in average grams per day in the past week)
Changes in alcohol use quantity
Time frame: 6 months
Alcohol use quantity (measured in average grams per day in the past week)
Changes in alcohol use frequency
Time frame: 1 month
Alcohol use frequency (measured in drinking days in the past week)
Changes in alcohol use frequency
Time frame: 3 months
Alcohol use frequency (measured in drinking days in the past week)
Changes in alcohol use frequency
Time frame: 6 months
Alcohol use frequency (measured in drinking days in the past week)
Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
Time frame: 1 month
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
Time frame: 3 months
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
Time frame: 6 months
Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores; Scale (0 to 15); Higher scores indicate harmful alcohol use.
12 secondary outcomes
Changes in anxiety
Time frame: 1 months
Changes in anxiety
Time frame: 3 months
Changes in anxiety
Time frame: 6 months
Changes in depression
Time frame: 1 months
Changes in depression
Time frame: 3 months
Changes in depression
Time frame: 6 months
Changes in quality of life
Time frame: 1 month
Changes in quality of life
Time frame: 3 months
Changes in quality of life
Time frame: 6 months
Packs of cigarettes smoked in the past week
Time frame: 1 month
Packs of cigarettes smoked in the past week
Time frame: 3 months
Packs of cigarettes smoked in the past week
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Shield principal investigator
Centre for Addiction and Mental Health
Questions about this trial
What is this clinical trial studying?
A study testing PAHOLA (digital health assistant) and Standard information on alcohol use and health in people with Alcohol Drinking and Alcoholism, run by Centre for Addiction and Mental Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alcohol use quantity (time frame: 1 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.