A Randomized Pilot Trial Investigating a Novel Mobile Application for Practicing Exercises from ACT
NCT ID: NCT06647121
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-10-31
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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).
Interventions
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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.
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.
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).
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Barbel Knauper
OTHER
Responsible Party
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Barbel Knauper
James McGill Professor of Health Psychology
Principal Investigators
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Bärbel Knäuper, PhD
Role: PRINCIPAL_INVESTIGATOR
McGill University
Locations
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McGill University
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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REB# 23-08-055
Identifier Type: -
Identifier Source: org_study_id
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