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Clinical Trials/NCT05211960
NCT05211960CompletedNot Applicable

Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Centre for Addiction and Mental Health2 sites in 1 country193 target enrollmentStarted: January 24, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
193
Locations
2
Primary Endpoint
WHO Disability Assessment Schedule (WHODAS 2.0) Short Form

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

All participants will be recruited knowing that a mindfulness app will be provided.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18-65 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

WHO Disability Assessment Schedule (WHODAS 2.0) Short Form

Time Frame: 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 Outcomes

  • Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)(30 days)
  • Perceived Stress Scale(30 days)
  • MHealth App Usability Questionnaire(30 days)
  • Patient Health Questionnaire (PHQ-9) Depression Subscale(14 days)
  • Generalized Anxiety Disorder 7 (GAD-7) Scale(14 days)
  • Work Productivity and Activity Impairment(30 days)
  • Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)(30 days)
  • Repetitive Thinking Questionnaire(30 days)
  • Penn State Worry Questionnaire(30 days)
  • Treatment Acceptability Questionnaire (Hunsley, 1992)(30 days)
  • Philadelphia Mindfulness Scale(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lena Quilty

Senior Scientist

Centre for Addiction and Mental Health

Study Sites (2)

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