Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Not Applicable

Completed

• Conditions: Mental Disorder
• Interventions: Behavioral: Mindfulness-based meditation

• Registration Number: NCT05211960
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

The purpose of this study is to evaluate a mindfulness-based meditation app provided to outpatients (or community participants) who are waitlisted for standard psychological care for mental health or substance use concerns.

Detailed Description

This project aims to provide a previously validated mindfulness meditation app to up to 200 adults waitlisted for psychological services in a psychiatric hospital setting or in the broader community. Outpatients (or community participants) who have been referred to and waitlisted for treatment for their mood, anxiety, alcohol, and/or substance use concerns, will be offered access to the digital intervention for 1 year. We will follow participants for 3 months to evaluate usability and psychological symptoms.

Study Timeline

• Study First Submitted: 2022-01-14
• Study Start: 2022-01-24
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-27
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

Inclusion Criteria

1. 18-65 years of age
2. Fluency in English
3. Understanding and willingness to comply with study requirements
4. Waitlisted for outpatient psychosocial programming at CAMH (or psychosocial programming in the community)
5. Smartphone or tablet capable of downloading and running the mindfulness app.

Exclusion Criteria

1. Any known practical factor that would preclude participation (e.g., extended absences)
2. Acute psychiatric (e.g., acute suicidality, psychosis) or serious medical condition that precludes participation in this study.
3. Participation in another treatment/intervention study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Mindfulness-based meditation	AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness. Participants will receive a premium account for 1 year; the current study will evaluate outcomes over 3 months. The intervention will be delivered concurrently with treatment as usual which includes standard psychosocial care as participants are referred to their respective programs.

Primary Outcome Measures

Name	Time	Method
WHO Disability Assessment Schedule (WHODAS 2.0) Short Form	30 days	Level of functional disability in the past month across six subdomains. Minimum score: 0, Maximum score: 48. Higher scores mean worse outcome.

Secondary Outcome Measures

Name	Time	Method
Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)	30 days	Measure of five core mindfulness skills over the past month (15 items). Minimum score: 15, Maximum score: 75. Higher scores mean greater dispositional mindfulness (good outcome).
Perceived Stress Scale	30 days	Well-validated measure of perceived stress over the past month (10 items). Minimum score: 0, Maximum score: 40. Higher scores mean greater perceived stress (worse outcome).
MHealth App Usability Questionnaire	30 days	An 18-item measure of the ease of use, acceptability as a treatment, and satisfaction. Minimum score: 18, Maximum score: 126. Higher scores indicate greater usability and satisfaction.
Patient Health Questionnaire (PHQ-9) Depression Subscale	14 days	Level of depressive symptoms over the past two weeks. Minimum score: 0, Maximum score: 27. Higher scores mean worse outcome.
Generalized Anxiety Disorder 7 (GAD-7) Scale	14 days	Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.
Work Productivity and Activity Impairment	30 days	Measure of disruption to work and activities because of mental health symptoms in the past month using 5 items. Scores vary as the scale utilizes open response options to some questions. Higher scores generally indicate more impairment to productivity.
Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)	30 days	Measure of ruminative thought patterns over the past 30 days using 10 items. Minimum score: 10, Maximum score: 40. Higher scores mean greater tendency to ruminate (worse outcome).
Repetitive Thinking Questionnaire	30 days	Measure of negative repetitive thought patterns over the past 30 days using 10 items. Minimum score: 10, Maximum score: 50. Higher scores mean greater tendency to experience repetitive thinking (worse outcome).
Penn State Worry Questionnaire	30 days	Measure of worry and rumination over the past 30 days using 16 items. Minimum score: 16, Maximum score: 80. Higher scores mean greater tendency to worry (worse outcome).
Treatment Acceptability Questionnaire (Hunsley, 1992)	30 days	Assesses the patient's perception of the treatment as useful, helpful, and effective using 6 items. Minimum score: 6, Maximum score: 42. Higher scores indicate greater acceptability.
Philadelphia Mindfulness Scale	30 days	Measure of mindful acceptance and awareness over the past month (20 items). Minimum score: 20, Maximum score: 100. Higher scores mean greater dispositional mindfulness (good outcome).

Trial Locations

Locations (1)

Campbell Family Mental Health Research Institute, CAMH; 🇨🇦 Toronto, Ontario, Canada