Clinical trial NCT06647121: A Randomized Pilot Trial Investigating a Novel Mobile Application for Practicing Exercises from ACT
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Distress
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Intervention adherence (home practice of mindfulness exercise)
timeFrame: 2 weeks
measure: ACTaide mobile app acceptability
timeFrame: 2 weeks
measure: Participant retention
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in Symptoms of Depression, Anxiety, Stress
timeFrame: 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.
measure: Changes in Mindfulness Skills
timeFrame: 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.
measure: Changes in Distress Tolerance
timeFrame: 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.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: Bärbel Knäuper, PhD
role: PRINCIPAL_INVESTIGATOR
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