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Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Primary Purpose

Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-based meditation
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorder focused on measuring mindfulness, digital health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Campbell Family Mental Health Research Institute, CAMHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Generalized Anxiety Disorder 7 (GAD-7) Scale
Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.
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).
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).
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).
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).
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).
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).
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.
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.
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.

Full Information

First Posted
January 14, 2022
Last Updated
February 6, 2023
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05211960
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder
Keywords
mindfulness, digital health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All participants will be recruited knowing that a mindfulness app will be provided.
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based meditation
Other Intervention Name(s)
AmDTx
Intervention Description
AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness.
Primary Outcome Measure Information:
Title
WHO Disability Assessment Schedule (WHODAS 2.0) Short Form
Description
Level of functional disability in the past month across six subdomains. Minimum score: 0, Maximum score: 48. Higher scores mean worse outcome.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9) Depression Subscale
Description
Level of depressive symptoms over the past two weeks. Minimum score: 0, Maximum score: 27. Higher scores mean worse outcome.
Time Frame
14 days
Title
Generalized Anxiety Disorder 7 (GAD-7) Scale
Description
Level of generalized anxiety symptoms over the past two weeks. Minimum score: 0, Maximum score: 21. Higher scores mean worse outcome.
Time Frame
14 days
Title
Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)
Description
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).
Time Frame
30 days
Title
Philadelphia Mindfulness Scale
Description
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).
Time Frame
30 days
Title
Perceived Stress Scale
Description
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).
Time Frame
30 days
Title
Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)
Description
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).
Time Frame
30 days
Title
Repetitive Thinking Questionnaire
Description
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).
Time Frame
30 days
Title
Penn State Worry Questionnaire
Description
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).
Time Frame
30 days
Title
Work Productivity and Activity Impairment
Description
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.
Time Frame
30 days
Title
Treatment Acceptability Questionnaire (Hunsley, 1992)
Description
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.
Time Frame
30 days
Title
MHealth App Usability Questionnaire
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lena C. Quilty, Ph.D.
Phone
416-535-8501
Ext
34313
Email
Lena.Quilty@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander R. Daros, Ph.D.
Phone
416-535-8501
Ext
30493
Email
alexander.daros@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C. Quilty, Ph.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campbell Family Mental Health Research Institute, CAMH
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2S1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena C. Quilty, PhD
Phone
416-535-8501
Ext
34313
Email
Lena.Quilty@camh.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.camh.ca
Description
Information about research at the Centre for Addiction and Mental Health
URL
https://camhstudies.ca/cgi-bin/findCAMHstudy_study.php?d=1312
Description
Study webpage

Learn more about this trial

Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

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