A Randomized Pilot Trial Investigating a Novel Mobile Application for Practicing Exercises from ACT

NCT06647121 | Not Yet Recruiting

• 1 other identifier: REB# 23-08-055
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness-related skills are associated with positive mental health outcomes and can be effectively taught through mobile apps. However, further research is needed to determine how best to support skill acquisition through the delivery of mindfulness exercises via smartphone apps. ACTaide is a novel mobile app designed to support home practice of mindfulness-related skills through exercises presented as stepwise annotated image sequences. The primary objective of this pilot and feasibility trial is to evaluate the feasibility of a prototype version of ACTaide. This two-arm parallel single-blinded (blinded participants) pilot trial will be conducted virtually with distressed Canadian adults. Participants (N = 60) will be recruited through the online platform Prolific. The intervention group will receive an Acceptance and Commitment Therapy (ACT) psychoeducational workshop and access to ACTaide for two weeks to support home practice of a mindfulness exercise from ACT: dropping anchor. The control group will receive the same psychoeducational workshop and access to a reminders-only mobile app to support their practice of the dropping anchor exercise. The main outcome measures will assess intervention feasibility, including adherence to the intervention, acceptability of the app, and retention rates. In addition, measures related to mindfulness-related skills and psychological distress will be collected. Prespecified progression criteria will be used to determine whether and how to proceed to a future trial designed to investigate the efficacy of ACTaide.

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (3)

• Intervention adherence (home practice of mindfulness exercise)

  the frequency and duration of home practice of a mindfulness exercise measured via the mobile app

  2 weeks

• ACTaide mobile app acceptability

  an adapted version of the mHealth App Usability Questionnaire (MAUQ; Zhou et al., 2019) will be used to measure the acceptability of the app.

  2 weeks

• Participant retention

  retention rates will be measured at the post-intervention and 2-week follow-up time points

  4 weeks

Secondary Outcomes (3)

• Changes in Symptoms of Depression, Anxiety, Stress

  Changes in psychological distress will be measured from baseline to the 2-week, post-intervention time point, and from baseline to the four-week, follow-up time point.

• Changes in Mindfulness Skills

  Changes in mindfulness skills will be measured from baseline to the two-week, post-intervention time point, and from baseline to the four-week, follow-up time point.

• Changes in Distress Tolerance

  Changes in distress tolerance will be measured from baseline to the two-week, post-intervention time point and from baseline to the four-week, follow-up time point.

Study Arms (2)

ACT Workshop Plus ACTaide Mobile App

EXPERIMENTAL

In this condition, participants will attend a 1-hour virtual ACT psychoeducational workshop where they will learn about ACT, practice the dropping anchor exercise (with a guided image sequence), and learn how to use the ACTaide mobile app, which they will be asked to use to practice the dropping anchor exercise daily for two weeks. The main feature of the ACTaide app is the annotated image sequence to guide users through the steps of the exercise. The app also features customizable reminders notifications. Participants will receive three reminders per day encouraging them to practice the exercise.

Behavioral: ACT Psychoeducational Workshop; Behavioral: ACTaide Mobile App

ACT Workshop Plus Reminders-only Mobile App

ACTIVE COMPARATOR

In this condition, participants will attend a 1-hour virtual ACT psychoeducational workshop where they will learn about ACT, practice the dropping anchor exercise (without a guided image sequence), and learn how to use the reminders-only mobile app, which they will be asked to use to practice the dropping anchor exercise daily for two weeks. This app will not include the annotated image sequence from ACTaide and instead will only include customizable reminders notifications. Participants will receive three reminders per day encouraging them to practice the exercise.

Behavioral: ACT Psychoeducational Workshop; Behavioral: Reminders-only mobile app

Interventions

ACT Psychoeducational Workshop BEHAVIORAL

The 1-hour ACT psychoeducational workshop will introduce participants to Acceptance and Commitment Therapy and include guided practice of the mindfulness exercise that they will be asked to practice for two weeks.

ACT Workshop Plus ACTaide Mobile App; ACT Workshop Plus Reminders-only Mobile App

ACTaide Mobile App BEHAVIORAL

The ACTaide mobile app is a novel app that is designed to support home practice of exercises from ACT via annotated image sequences and reminder notifications. A prototype version that features the dropping anchor mindfulness exercise will be investigated in this study.

ACT Workshop Plus ACTaide Mobile App

Reminders-only mobile app BEHAVIORAL

This app will include only reminder notifications to encourage home practice of the dropping anchor mindfulness exercise in the comparator condition. It will not include the annotated image sequence for the exercise (i.e., the primary feature of the ACTaide app to be investigated in the intervention condition).

ACT Workshop Plus Reminders-only Mobile App

Eligibility Criteria

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

You may qualify if:

• be at least 18 years old;
• be fluent in English;
• own a smartphone with a data plan;
• report at least moderate psychological distress as measured by the 21-item Depression Anxiety Stress Scales (DASS-21; i.e., overall score of at least 43); and
• report at least moderate motivation to learn a new psychotherapeutic exercise for navigating psychological distress (i.e., at least 6 out of 10).

You may not qualify if:

• Due to the limited psychotherapeutic scope of the intervention, individuals were ineligible if they self-reported extremely severe psychological distress (i.e., an overall score of 82 or higher on the DASS-21) or a diagnosis of a severe mental illness (i.e., bipolar disorder, psychosis, schizophrenia, borderline personality disorder).

Sponsors & Collaborators

• Barbel Knauper: lead

Study Sites (1)

McGill University

Montreal, Quebec, H3A1G1, Canada

Location

Related Publications (13)

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Study Officials

• Bärbel Knäuper, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aidan Smyth, MSc

CONTACT

613-200-6806; aidan.smyth@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to condition assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: James McGill Professor of Health Psychology

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 17, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Data will be shared within approximately one year of the completion of data collection.
• Access Criteria: Data will be available to all researchers via the OSF website.

Locations

CA (1)