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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based meditation | Behavioral | AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Generalized Anxiety Disorder 7 (GAD-7) Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lena C. Quilty, Ph.D. | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Campbell Family Mental Health Research Institute, CAMH | Toronto | Ontario | M5S 2S1 | Canada |
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| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health | View source |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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All participants will be recruited knowing that a mindfulness app will be provided.
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Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.
| 14 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |