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

NCT ID: NCT05906979

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-09-01

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.

Conditions

Alcohol Drinking; Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Digital intervention

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

Group Type: EXPERIMENTAL

PAHOLA (digital health assistant)

Intervention Type: 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.

Digital intervention (text only)

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

Group Type: EXPERIMENTAL

PAHOLA (digital health assistant)

Intervention Type: 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.

Information on alcohol use and risk

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

Group Type: OTHER

Standard information on alcohol use and health

Intervention Type: OTHER

A brochure on alcohol use and health as produced by the Pan American Health Organization will be provided to participants.

Interventions

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.

Intervention Type: OTHER

Standard information on alcohol use and health

A brochure on alcohol use and health as produced by the Pan American Health Organization will be provided to participants.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Pan American Health Organization

OTHER

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Jurgen Rehm

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin Shield

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Central Contacts

Kevin Shield

Role: CONTACT

kevin.shield@camh.ca

416-535-8501 ext. 36768

Other Identifiers

2023-0615

Identifier Type: -

Identifier Source: org_study_id