Clinical trial NCT05211960: Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions
Official title: Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Keywords: mindfulness
digital health
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: WHO Disability Assessment Schedule (WHODAS 2.0) Short Form
timeFrame: 30 days
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9) Depression Subscale
timeFrame: 14 days
measure: Generalized Anxiety Disorder 7 (GAD-7) Scale
timeFrame: 14 days
measure: Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)
timeFrame: 30 days
measure: Philadelphia Mindfulness Scale
timeFrame: 30 days
measure: Perceived Stress Scale
timeFrame: 30 days
measure: Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)
timeFrame: 30 days
measure: Repetitive Thinking Questionnaire
timeFrame: 30 days
measure: Penn State Worry Questionnaire
timeFrame: 30 days
measure: Work Productivity and Activity Impairment
timeFrame: 30 days
measure: Treatment Acceptability Questionnaire (Hunsley, 1992)
timeFrame: 30 days
measure: MHealth App Usability Questionnaire
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Campbell Family Mental Health Research Institute, CAMH
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Lena C. Quilty, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: