Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

NCT05211960 | Completed

• 1 other identifier: 088/2021
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder

Keywords

mindfulness; digital health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient Health Questionnaire (PHQ-9) Depression Subscale

  14 days

• Generalized Anxiety Disorder 7 (GAD-7) Scale

  14 days

• Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)

  30 days

• Philadelphia Mindfulness Scale

  30 days

• Perceived Stress Scale

  30 days

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Mindfulness-based meditation BEHAVIORAL

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

Also known as: AmDTx

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Fluency in English
• Understanding and willingness to comply with study requirements
• Waitlisted for outpatient psychosocial programming at CAMH (or psychosocial programming in the community)
• Smartphone or tablet capable of downloading and running the mindfulness app.

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Campbell Family Mental Health Research Institute, CAMH

Toronto, Ontario, M5S 2S1, Canada

Location

Related Links

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

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Lena C. Quilty, Ph.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants will be recruited knowing that a mindfulness app will be provided.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: January 24, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)