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

NCT05906979 | Withdrawn

• 1 other identifier: 2023-0615
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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. 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. 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.

Conditions

Alcohol Drinking; Alcoholism

Outcome Measures

Primary Outcomes (9)

• Changes in alcohol use quantity

  Alcohol use quantity (measured in average grams per day in the past week)

  1 month

• Changes in alcohol use quantity

  Alcohol use quantity (measured in average grams per day in the past week)

  3 months

• Changes in alcohol use quantity

  Alcohol use quantity (measured in average grams per day in the past week)

  6 months

• Changes in alcohol use frequency

  Alcohol use frequency (measured in drinking days in the past week)

  1 month

• Changes in alcohol use frequency

  Alcohol use frequency (measured in drinking days in the past week)

  3 months

• Changes in alcohol use frequency

  Alcohol use frequency (measured in drinking days in the past week)

  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.

  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.

  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.

  6 months

Secondary Outcomes (12)

• Changes in anxiety

  1 months

• Changes in anxiety

  3 months

• Changes in anxiety

  6 months

• Changes in depression

  1 months

• Changes in depression

  3 months

Study Arms (3)

Digital intervention

EXPERIMENTAL

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

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.

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.

Other: Standard information on alcohol use and health

Interventions

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.

Digital intervention; Digital intervention (text only)

Standard information on alcohol use and health OTHER

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

Information on alcohol use and risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pan American Health Organization: collaborator
• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator

MeSH Terms

Conditions

Alcohol Drinking; Alcoholism

Interventions

Ethanol; Health

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Population Characteristics

Study Officials

• Kevin Shield

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 18, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share