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

October 16, 2024 updated by: Barbel Knauper

A Randomized Pilot and Feasibility Trial Investigating a Mobile Application-Delivered Mindfulness Exercise for Navigating Psychological Distress: Dropping Anchor Delivered As a Stepwise Image Sequence

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. be at least 18 years old;
  2. be fluent in English;
  3. own a smartphone with a data plan;
  4. 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
  5. report at least moderate motivation to learn a new psychotherapeutic exercise for navigating psychological distress (i.e., at least 6 out of 10).

Exclusion Criteria:

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT Workshop Plus ACTaide Mobile App
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
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.
Behavioral: ACTaide Mobile App
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.
Active Comparator: ACT Workshop Plus Reminders-only Mobile App
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
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.
Behavioral: Reminders-only mobile app
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention adherence (home practice of mindfulness exercise)
Time Frame: 2 weeks
the frequency and duration of home practice of a mindfulness exercise measured via the mobile app
2 weeks
ACTaide mobile app acceptability
Time Frame: 2 weeks
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
Time Frame: 4 weeks
retention rates will be measured at the post-intervention and 2-week follow-up time points
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Symptoms of Depression, Anxiety, Stress
Time Frame: 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.
The 21-item Depression, Anxiety, and Stress Scale (DASS-21; Lovibond & Lovibond, 1995) will be included. It is the proposed primary outcome of future efficacy trials. The DASS-21 is a self-report measure that assesses individuals' symptoms of depression, anxiety, and stress in the past week. Participants are asked to indicate the extent to which each statement applied to them over the past week from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). Sample items include: "I found it hard to wind down" and "I felt down-hearted and blue." Scores for each subscale will be computed by taking the sum of all items from each respective subscale and multiplying by two. To assess the efficacy potential of the intervention, we calculate the proportion of participants in each condition that reported clinically meaningful reductions in psychological distress at the post-intervention and follow-up time points.
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
Time Frame: 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 mindfulness skills, a proposed secondary outcome for future efficacy trials, will be measured with the Multidimensional Psychological Flexibility Inventory Short Form (MPFI-24; Grégoire et al., 2020; Rolffs et al., 2018), which is a 24-item self-report questionnaire that assesses components of Psychological Flexibility and Inflexibility as defined by the Hexaflex model of ACT. The measure includes pairs of items that assess each of the six components of Psychological Flexibility (e.g., Acceptance, Present Moment Awareness) and Psychological Inflexibility (e.g., Experiential Avoidance, Lack of Contact with the Present Moment). In addition, two measures of equanimity will be included as potential secondary outcome measures for future efficacy trials: (1) the Even-mindedness subscale from the Two-Factor Equanimity Scale (Juneau et al., 2020), and the Equanimity Scale-16 (ES-16; Rogers et al., 2021).
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
Time Frame: 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.
The Distress Tolerance Scale short-form (DTS-SF; Gardner et al., 2018) will be included. It is a 4-item scale that measures individuals' perceived ability to experience, endure, and regulate negative psychological states. Participants in the present study will be asked to respond to each item based on their experiences over the past week; therefore, items were modified to past tense (example item: "I couldn't handle feeling distressed or upset.")
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barbel Knauper

Investigators

  • Principal Investigator: Bärbel Knäuper, PhD, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • REB# 23-08-055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be uploaded to OSF after the completion of the study.

IPD Sharing Time Frame

Data will be shared within approximately one year of the completion of data collection.

IPD Sharing Access Criteria

Data will be available to all researchers via the OSF website.

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychological Distress

Clinical Trials on ACT Psychoeducational Workshop

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe