Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Mental Disorder Clinical Trial

Official title:

Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05211960
• Other study ID #: 088/2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders

Intervention

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

Locations

Country	Name	City	State
Canada	Campbell Family Mental Health Research Institute, CAMH	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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