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Completed

NCT Number: NCT05211960

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.

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Key information

Conditions

Mental Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campbell Family Mental Health Research Institute, CAMH

Toronto, Ontario, M5S 2S1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based meditation

Behavioral

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

Other names: AmDTx

Primary outcomes

  1. 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

  1. Patient Health Questionnaire (PHQ-9) Depression Subscale

    Time frame: 14 days

    Level of depressive symptoms over the past two weeks. Minimum score: 0, Maximum score: 27. Higher scores mean worse outcome.

  2. Generalized Anxiety Disorder 7 (GAD-7) Scale

    Time frame: 14 days

    Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.

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

    Time frame: 30 days

    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).

  4. Philadelphia Mindfulness Scale

    Time frame: 30 days

    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).

  5. Perceived Stress Scale

    Time frame: 30 days

    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).

  6. Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)

    Time frame: 30 days

    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).

  7. Repetitive Thinking Questionnaire

    Time frame: 30 days

    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).

  8. Penn State Worry Questionnaire

    Time frame: 30 days

    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).

  9. Work Productivity and Activity Impairment

    Time frame: 30 days

    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.

  10. Treatment Acceptability Questionnaire (Hunsley, 1992)

    Time frame: 30 days

    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.

  11. MHealth App Usability Questionnaire

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2022
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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