Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorder
• Intervention / Treatment: Behavioral: Mindfulness-based meditation

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 Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 2S1
      • Campbell Family Mental Health Research Institute, CAMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; 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.

Behavioral: Mindfulness-based meditation; AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness.; Other Names: AmDTx

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9) Depression Subscale	Level of depressive symptoms over the past two weeks. Minimum score: 0, Maximum score: 27. Higher scores mean worse outcome.	14 days
Generalized Anxiety Disorder 7 (GAD-7) Scale	Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.	14 days
Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)	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).	30 days
Philadelphia Mindfulness Scale	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).	30 days
Perceived Stress Scale	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).	30 days
Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)	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).	30 days
Repetitive Thinking Questionnaire	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).	30 days
Penn State Worry Questionnaire	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).	30 days
Work Productivity and Activity Impairment	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.	30 days
Treatment Acceptability Questionnaire (Hunsley, 1992)	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.	30 days
MHealth App Usability Questionnaire	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.	30 days

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Lena C. Quilty, Ph.D., Centre for Addiction and Mental Health

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health
• Study webpage

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 26, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; digital health
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: 088/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No