Clinical trial NCT05906979: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Drinking
Alcoholism
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Pan American Health Organization
First posted: 2023-06-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: TREATMENT

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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. Current drinkers 18 years of age and older who score 7 to 23 on the Alcohol Use Disorders Identification Test
2. Use of medication to treat harmful alcohol use will be allowed provided that the dose has been stable for 8 weeks
3. Availability of a computer with a connection to the internet and a camera and microphone

Exclusion Criteria:

1. A history of drug use disorders (other than alcohol) in the last two years (except tobacco use disorder)
2. Dose changes of concomitant medications will not be permitted during the study period
3. 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
4. People who are currently reciving psychological treatment for alcohol use disorders

Primary outcomes:
measure: Changes in alcohol use quantity
timeFrame: 1 month
measure: Changes in alcohol use quantity
timeFrame: 3 months
measure: Changes in alcohol use quantity
timeFrame: 6 months
measure: Changes in alcohol use frequency
timeFrame: 1 month
measure: Changes in alcohol use frequency
timeFrame: 3 months
measure: Changes in alcohol use frequency
timeFrame: 6 months
measure: Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
timeFrame: 1 month
measure: Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
timeFrame: 3 months
measure: Changes in Alcohol Use Disorders Identification Test (AUDIT) items 5 to 10 scores
timeFrame: 6 months
Secondary outcomes:
measure: Changes in anxiety
timeFrame: 1 months
measure: Changes in anxiety
timeFrame: 3 months
measure: Changes in anxiety
timeFrame: 6 months
measure: Changes in depression
timeFrame: 1 months
measure: Changes in depression
timeFrame: 3 months
measure: Changes in depression
timeFrame: 6 months
measure: Changes in quality of life
timeFrame: 1 month
measure: Changes in quality of life
timeFrame: 3 months
measure: Changes in quality of life
timeFrame: 6 months
measure: Packs of cigarettes smoked in the past week
timeFrame: 1 month
measure: Packs of cigarettes smoked in the past week
timeFrame: 3 months
measure: Packs of cigarettes smoked in the past week
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Kevin Shield
role: PRINCIPAL_INVESTIGATOR
References: