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Psychological DistressNCT06647121

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

A study testing ACT Psychoeducational Workshop, ACTaide Mobile App and Reminders-only mobile app in people with Psychological Distress, run by Barbel Knauper at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychological Distress
What is being tested?
ACT Psychoeducational Workshop, ACTaide Mobile App and Reminders-only mobile app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteCanada
Study dates
Oct 2024to May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aidan Smyth, MSc contact

613-200-6806

aidan.smyth@mail.mcgill.ca

Canada1 site

  • McGill University

    Montreal, Quebec, H3A1G1

    Aidan Smyth, MSc, 613-200-6806, aidan.smyth@mail.mcgill.ca

Other trials in Canada

About this study

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

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.

Being tested
ACT Psychoeducational Workshop, ACTaide Mobile App, Reminders-only mobile app

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT Psychoeducational WorkshopBehavioural

    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.

  • ACTaide Mobile AppBehavioural

    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.

  • Reminders-only mobile appBehavioural

    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).

Study groups in NCT06647121
Study groupRoleWhat they receive
ACT Workshop Plus ACTaide Mobile AppExperimentalIn 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.
Receives: Behavioral: ACT Psychoeducational Workshop; Behavioral: ACTaide Mobile App
ACT Workshop Plus Reminders-only Mobile AppActive comparatorIn 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.
Receives: Behavioral: ACT Psychoeducational Workshop; Behavioral: Reminders-only mobile app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intervention adherence (home practice of mindfulness exercise)

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

    Measured: 2 weeks

  2. 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.

    Measured: 2 weeks

  3. Participant retention

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

    Measured: 4 weeks

Secondary outcomes (3)

  1. 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.

    Measured: 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.

  2. 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).

    Measured: 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.

  3. 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.")

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647121
Sponsor's protocol ID
REB# 23-08-055
Status last verified
Oct 2024
First submitted
16 Oct 2024
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data will be uploaded to OSF after the completion of the study.

Publications

  • Di Sante J, Frayn M, Angelescu A, Knauper B. Proof-of-concept testing of a brief virtual ACT workshop for emotional eating. Appetite. 2024 Aug 1;199:107386. doi: 10.1016/j.appet.2024.107386. Epub 2024 Apr 30.

    PubMed 38692511

  • Dochat C, Wooldridge JS, Herbert MS, Lee MW, Afari N. Single-Session Acceptance and Commitment Therapy (ACT) Interventions for Patients with Chronic Health Conditions: A Systematic Review and Meta-Analysis. J Contextual Behav Sci. 2021 Apr;20:52-69. doi: 10.1016/j.jcbs.2021.03.003. Epub 2021 Mar 6.

    PubMed 33868913

  • Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

    PubMed 27777223

  • Frayn M, Khanyari S, Knauper B. A 1-day acceptance and commitment therapy workshop leads to reductions in emotional eating in adults. Eat Weight Disord. 2020 Oct;25(5):1399-1411. doi: 10.1007/s40519-019-00778-6. Epub 2019 Sep 20.

    PubMed 31541426

  • Kazdin AE. Annual Research Review: Expanding mental health services through novel models of intervention delivery. J Child Psychol Psychiatry. 2019 Apr;60(4):455-472. doi: 10.1111/jcpp.12937. Epub 2018 Jun 13.

    PubMed 29900543

  • Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.

    PubMed 16651505

  • Lewis M, Bromley K, Sutton CJ, McCray G, Myers HL, Lancaster GA. Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud. 2021 Feb 3;7(1):40. doi: 10.1186/s40814-021-00770-x.

    PubMed 33536076

  • Linardon J, Fuller-Tyszkiewicz M. Attrition and adherence in smartphone-delivered interventions for mental health problems: A systematic and meta-analytic review. J Consult Clin Psychol. 2020 Jan;88(1):1-13. doi: 10.1037/ccp0000459. Epub 2019 Nov 7.

    PubMed 31697093

  • Linardon J, Torous J, Firth J, Cuijpers P, Messer M, Fuller-Tyszkiewicz M. Current evidence on the efficacy of mental health smartphone apps for symptoms of depression and anxiety. A meta-analysis of 176 randomized controlled trials. World Psychiatry. 2024 Feb;23(1):139-149. doi: 10.1002/wps.21183.

    PubMed 38214614

  • Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

    PubMed 7726811

  • Patel V, Maj M, Flisher AJ, De Silva MJ, Koschorke M, Prince M; WPA Zonal and Member Society Representatives. Reducing the treatment gap for mental disorders: a WPA survey. World Psychiatry. 2010 Oct;9(3):169-76. doi: 10.1002/j.2051-5545.2010.tb00305.x.

    PubMed 20975864

  • Ronk FR, Korman JR, Hooke GR, Page AC. Assessing clinical significance of treatment outcomes using the DASS-21. Psychol Assess. 2013 Dec;25(4):1103-10. doi: 10.1037/a0033100. Epub 2013 Jun 3.

    PubMed 23730826

  • Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500.

    PubMed 30973342

Questions about this trial

What is this clinical trial studying?

A study testing ACT Psychoeducational Workshop, ACTaide Mobile App and Reminders-only mobile app in people with Psychological Distress, run by Barbel Knauper at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aidan Smyth, MSc (613-200-6806, aidan.smyth@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intervention adherence (home practice of mindfulness exercise) (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06647121, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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