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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
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).
McGill University
Montreal, Quebec, Canada
Intervention adherence (home practice of mindfulness exercise)
the frequency and duration of home practice of a mindfulness exercise measured via the mobile app
Time frame: 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.
Time frame: 2 weeks
Participant retention
retention rates will be measured at the post-intervention and 2-week follow-up time points
Time frame: 4 weeks
Changes in Symptoms of Depression, Anxiety, Stress
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.
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.
Changes in Mindfulness Skills
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).
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 Distress Tolerance
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.")
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.
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