ACTaide Mobile App for Psychological Distress

Overseen By Aidan Smyth, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Barbel Knauper

Disqualifiers: Severe distress, Bipolar, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bärbel Knäuper, PhD

Principal Investigator

McGill University

Eligibility Criteria

This trial is for Canadian adults experiencing psychological distress. Participants must be willing to use a mobile app and attend an online psychoeducational workshop. They should have access to the internet and a smartphone.

Inclusion Criteria

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)

I am quite motivated (at least 6/10) to learn new ways to handle stress.

Be fluent in English

Exclusion Criteria

Diagnosis of a severe mental illness (i.e., bipolar disorder, psychosis, schizophrenia, borderline personality disorder)

Self-reported extremely severe psychological distress (i.e., an overall score of 82 or higher on the DASS-21)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive a 1-hour virtual ACT psychoeducational workshop and use the ACTaide or reminders-only mobile app for daily practice of the dropping anchor exercise

2 weeks

Virtual participation

Follow-up

Participants are monitored for changes in mindfulness skills and psychological distress

4 weeks

Treatment Details

Interventions

• ACTaide Mobile App
• ACT Psychoeducational Workshop
• Reminders-only mobile app

Trial Overview The study tests ACTaide, a new mobile app designed to help users practice mindfulness exercises from Acceptance and Commitment Therapy (ACT). It's compared with a control group using just reminders. The focus is on how well participants stick with the program, like the app, and continue in the study.

Participant Groups

Group I: ACT Workshop Plus ACTaide Mobile App Experimental Treatment 2 Interventions

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.

Group II: ACT Workshop Plus Reminders-only Mobile App Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Barbel Knauper

Lead Sponsor

Trials

1

Recruited

60+