Mental DisorderNCT05211960
Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions
A study testing Mindfulness-based meditation in people with Mental Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Mindfulness-based meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Campbell Family Mental Health Research Institute, CAMH
Toronto, Ontario, M5S 2S1
About this study
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.
Read the 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.
- Conditions
- Mental Disorder
- Being tested
- Mindfulness-based meditation
- Keywords
- mindfulness, digital health
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based meditationBehavioural
Also called AmDTx
AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-based meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (11)
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.
Measured: 14 days
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start24 Jan 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C. Quilty, Ph.D., Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211960
- Sponsor's protocol ID
- 088/2021
- Status last verified
- Aug 2024
- First submitted
- 14 Jan 2022
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions
- ClinicalTrials.gov ID
- NCT05211960
- Acronym / sponsor ID
- 088/2021
- Conditions
- Mental Disorder
- Keywords
- mindfulness, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Mindfulness-based meditationAmDTx 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based meditationAlso: AmDTxAmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness. | Behavioural | Treatment |
Primary outcome
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.
11 secondary outcomes
Patient Health Questionnaire (PHQ-9) Depression Subscale
Time frame: 14 days
Generalized Anxiety Disorder 7 (GAD-7) Scale
Time frame: 14 days
Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)
Time frame: 30 days
Philadelphia Mindfulness Scale
Time frame: 30 days
Perceived Stress Scale
Time frame: 30 days
Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)
Time frame: 30 days
Repetitive Thinking Questionnaire
Time frame: 30 days
Penn State Worry Questionnaire
Time frame: 30 days
Work Productivity and Activity Impairment
Time frame: 30 days
Treatment Acceptability Questionnaire (Hunsley, 1992)
Time frame: 30 days
MHealth App Usability Questionnaire
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
- Study webpageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena C. Quilty, Ph.D. principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based meditation in people with Mental Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHO Disability Assessment Schedule (WHODAS 2.0) Short Form (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.