A4i-O: A Platform for Complex Behavioral Health to Address OUD

NCT06215963 | Completed

• 1 other identifier: 042/2022
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

For the purposes of beta testing the first version of A4i-O, 15 individuals with OUD will use the platform for one month. From a design perspective this sample size is viewed as being sufficient to answer questions regarding app functionality and feasibility before moving to larger trials. Additionally, 15 individuals is a larger sample size than in the A4i pilot. This is an open label pilot with a primary objective of troubleshooting and providing early feedback on the beta version of the technology. To that end, 15 participants are anticipated to be sufficient to provide robust, early feedback. As with the focus groups, through sampling an effort will be made to secure a diverse group. Any individuals who might be declined in that effort at this stage (e.g., it is determined that no more male identifying participants are needed but they were interested) would be invited to take part in the subsequent RCT.

Conditions

Opioid-Related Disorders; Relationship, Professional Patient; Mental Health Wellness 1; Mobile Phone Use; Comorbidities and Coexisting Conditions

Keywords

Opioid Use Disorder; Digital Health Intervention; Substance Use; Mental Health and Wellness

Outcome Measures

Primary Outcomes (6)

• A4i-O Total Time Used

  Total time spent on the A4i-O app will be measured for each participant.

  1 month

• A4i-O Login Frequency

  Number of times participants login to the A4i-O app will be calculated.

  1 month

• A4i-O Nature of Use Metrics

  The frequency and type of A4i-O features used by each participant will be measured.

  1 month

• A4i-O Feedback from Participants and Providers

  The Research Personnel will contact both providers and participants to complete a brief semi-structured interview assessing strengths (generally and in clinical interactions) and limitations of A4i-O and any risks not otherwise reported or observed during study operations.

  1 month

• Participant Satisfaction with A4i-O

  Participant satisfaction with the technology will also be examined using the 26-item Acceptability/Usability Digital Health Technology scale used by Ben-Zeev and colleagues (2). Minimum values: -1, maximum values: 1, with a higher score indicating increased satisfaction (better outcome).

  1 month

• Safety and Critical Incidents

  Safety will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and A4i-O use.

  1 month

Secondary Outcomes (4)

• General Symptom Severity

  1 month

• Substance Use Dependence

  1 month

• Treatment Engagement

  1 month

• General Adherence to Treatment

  1 month

Study Arms (1)

App for Independence-O (A4i-O)

EXPERIMENTAL

Participants will be provided with A4i-O for one month.

Device: App for Independence-O (A4i-O)

Interventions

App for Independence-O (A4i-O) DEVICE

A4i-O is a digital health platform designed to support individuals with opioid use disorders. A4i-O will focus on providing education on treatment options, recovery navigation, social activation and connections to a range of resources. It aims to assist with fostering self-management and recovery through identifying risks for relapse, navigating urges/cravings, coping with shame/guilt, avoiding relapse, moving forward after relapse, and lived experiences. Daily wellness and goal attainment check-ins to highlight mental health trajectories will be prompted. With appropriate consent from both the client and provider, a provider dashboard is accessible to the client's provider prior to their appointment, generating a summary of day-to-day wellness ratings, responses to reminders, goal progressions, and other self-reported measures from the platform.

App for Independence-O (A4i-O)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be adults, 18 years of age or older, with a provider-assigned diagnosis of OUD confirmed by the SCID-5. Electronic medical records will be accessed for CAMH clients after informed consent is obtained to confirm the OUD diagnosis. For clients who were recruited externally and do not have a CAMH chart, confirmation of diagnosis will be sought from the referring clinician.
• All participants will be engaged in outpatient psychiatric treatment for OUD.
• All participants will currently be engaged in opioid agonist treatment.
• Proficiency in English via ability to understand written/verbal communication during consent process. Any RA concerns about ability to understand English will be brought to the PI for determination of next steps (see consent procedures below).
• Own and use an Android or iOS smartphone.
• All participants will be open to having their care provider participate in the study

You may not qualify if:

• Lack of capacity to consent.
• Intellectual disability.
• Experiencing distress at a level that would affect research and technology engagement (e.g., acute suicidality).
• Criteria (service providers): Service providers will be psychiatrists and case managers engaged in the care of the participants.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6R2C4, Canada

Location

Related Publications (5)

• Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

  PMID: 16204405 BACKGROUND

• Ben-Zeev D, Brenner CJ, Begale M, Duffecy J, Mohr DC, Mueser KT. Feasibility, acceptability, and preliminary efficacy of a smartphone intervention for schizophrenia. Schizophr Bull. 2014 Nov;40(6):1244-53. doi: 10.1093/schbul/sbu033. Epub 2014 Mar 8.

  PMID: 24609454 BACKGROUND

• Derogatis, L.R.(1993). BSI Brief Symptom Inventory: Administration, Scoring, and Procedure Manual (4th Ed.). Minneapolis, MN: National Computer Systems.

  BACKGROUND

• Byerly MJ, Nakonezny PA, Rush AJ. The Brief Adherence Rating Scale (BARS) validated against electronic monitoring in assessing the antipsychotic medication adherence of outpatients with schizophrenia and schizoaffective disorder. Schizophr Res. 2008 Mar;100(1-3):60-9. doi: 10.1016/j.schres.2007.12.470. Epub 2008 Feb 5.

  PMID: 18255269 BACKGROUND

• Sherbourne CD, Hays RD, Ordway L, DiMatteo MR, Kravitz RL. Antecedents of adherence to medical recommendations: results from the Medical Outcomes Study. J Behav Med. 1992 Oct;15(5):447-68. doi: 10.1007/BF00844941.

  PMID: 1447757 BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders; Cell Phone Use; Substance-Related Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Communication; Behavior; Social Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: January 22, 2024
• Study Start: February 5, 2024
• Primary Completion: August 30, 2024
• Study Completion: November 1, 2024
• Last Updated: April 22, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CA (1)