AzTrials
AzTrials

Psychological StressNCT03908918

Mind and Body:A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention

A study testing Mindfulness app in people with Psychological Stress and Psychological Distress, run by Providence Healthcare at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study evaluates the use of a mobile-app delivered mindfulness-based intervention for supporting psychosocial resilience in aging patients undergoing rehabilitation treatment. Half of the patients will receive the mobile-app, while the other half will receive the app 6 months later. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Mindfulness app
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteCanada
Study dates
1 Apr 2019to 30 Sep 2019
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women over the age of 40.
  • Admitted as In-Patients.
  • Access to a smart phone with data connection.
  • Willing to give time for mindfulness practice.
  • Sufficient ability to speak and read English.
  • Willingness to be randomized into immediate or waitlist groups and complete all assessments.

Who cannot join

  • Any cognitive or mental impairment that would interfere with completing questionnaires or the intervention (<6 on the Brief Screen for Cognitive Impairment) .
  • Admitted to Providence as an in-patient to long-term care or palliative care.
  • An existing smartphone app-based mindfulness practice consisting of one or more sessions per week.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Providence Healthcare

    Toronto, Ontario, M1L1W1

Other trials in Canada

About this study

Official title: Mind and Body: A Clinical Trial Evaluation of a Smartphone App-based Mindfulness Intervention to Support Psychosocial Resilience in Aging Patients

This study evaluates the use of a mobile-app delivered mindfulness-based intervention for supporting psychosocial resilience in aging patients undergoing rehabilitation treatment. Half of the patients will receive the mobile-app, while the other half will receive the app 6 months later.

Read the detailed description

Although, several mobile-app based MBTs are available in the marketplace, there is scant evidence of high scientific rigor to support their therapeutic efficacy. Furthermore, the tracking of wellness outcomes, stress resilience and functioning as a result of use of a therapeutic digital product is a challenging task requiring expertise in technology. In this study, the investigators aim to investigate not only the effectiveness of an app-based MBT in aging adults, but also the mechanisms of efficacy - i.e. the therapeutic effects - of app usage, including changes in, depression, anxiety, or mood and the acceptance of the app in older adult populations. The investigators also aim to measure the Return On Investment (ROI) of mobile mindfulness on health services utilization.

The study is a randomized controlled design with 1:1 equal allocation to treatment (Experimental Am app group) or control (treatment as usual). The investigators will recruit 82 participants in total.

The Experimental group will start the 4 week Am app intervention immediately after randomization and baseline intervention questionnaires, while the wait-list control group will receive treatment as usual. Assessments are conducted at four time point: At Baseline (#1), Post-Intervention (#2), Follow-up at 3 months post baseline (#3) and Follow-up at 6 months post baseline (#4).

The clinical champions that referred the patient to the study will complete brief surveys about the quality of their appointments with the patient at two time points: At baseline (#1) and Post-Intervention (#2).

The waitlist control group will be granted access to the mindfulness intervention at 6 months post baseline.

Being tested
Mindfulness app
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness appOther

    Also called Am

    Mobile app-delivered mindfulness intervention delivered over 4 weeks.

Study groups in NCT03908918
Study groupRoleWhat they receive
Active groupExperimentalMobile-app delivered mindfulness intervention. Dosage: 4 times per week for 4 weeks
Receives: Other: Mindfulness app
Waitlist controlOtherWaitlist control - receiving the app after 6 months
Receives: Other: Mindfulness app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Outcome: Cost of treatment; Measure: Duration of stay

    To evaluate the cost-benefit measures of the Am smartphone-app by measuring length of stay in hospital and levels of health services utilization

    As no Electronic Health Records (EHR) are kept by Providence, a chart review, including progress notes, will be required to assess the following:

    • Date of admission.
    • Date of discharge.

    Measured: 6 months

  2. Outcome: Health services utilization; measure: survey questions

    Cost of Treatment will also be measured using patient self-reports of health services utilization at 3 and 6 months post intervention. Participants will answer five questions related to their use of health services utilization drawn from peer-reviewed literature (Van den Brink et al., 2005).

    1. Compared to the 3 months prior to the study, in the past 3 months my use of health care services has: (1) greatly decreased (2) stayed the same (3) greatly increased
    2. How many times did you visit your doctor's office visits in the last 3 months?
    3. How many times a caregiver visit you in your home in the last 3 months?
    4. How many times were you admitted to a hospital in the last 3 months.

    Measured: 6 months

  3. Outcome: Cost of treatment; Measure: Discharge destination

    Indicates whether the patient returns home, or is discharged to another care facility (e.g., long term or palliative care).

    Measured: 6 months

  4. Outcome: Cost of treatment; Measure: Alternate Level of Care (ALC) assignment.

    If Alternate Level of Care (ALC) assigned, the reasons underlying the decision. The term ALC is a clinical designation that identifies patients who no longer require the intensity of resources or services provided in their current settings and who are wait

    Measured: 6 months

  5. Outcome: Cost of treatment; Measure: National Rehabilitation Reporting System (NRS) assessments.

    The NRS minimum data set contains clinical data on functional status based on the 18-item Functional Independence Measure (FIM®) instrument.

    FIM™ is comprised of 18 items, grouped into 2 subscales - motor and cognition.

    Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.

    1. - Total assistance with helper
    2. - Maximal assistance with helper
    3. - Moderate assistance with helper
    4. - Minimal assistance with helper
    5. - Supervision or setup with helper
    6. - Modified independence with no helper
    7. - Complete independence with no helper

    Measured: 6 months

  6. Outcome: Cost of treatment; Measure: Rehabilitation Patient Group (RPG)

    The NRS gives an RPG score used to categorize patient data based on their primary reason for receiving inpatient rehabilitation services.

    Based on a patient's primary reason for receiving inpatient rehabilitation services, and using client age at admission and motor and cognitive functional status, patient's are assigned to one of 83 RPGs.

    Measured: 6 months

  7. Outcome: Cost of treatment; Measure: number of clinic visits

    Post six-month retrospective report of patients' clinic visits.

    Measured: 6 months

Secondary outcomes (12)

  1. Outcome: stress; Measure: NIH Toolbox Perceived Stress Fixed Form (Age 18+ v2.0)

    To evaluate the efficacy of the Am smartphone-app to relieve symptoms of stress

    The NIH Toolbox Perceived Stress Fixed Form contains measures in the domains of emotional health and was designed for use in epidemiological and clinical trials health-related research. It was selected for inclusion and subsequent national norming for the NIH Toolbox based on its psychometric performance.

    Measured: 6 months

  2. Outcome: Impact on health-related quality of life; Measure: PROMIS57

    To evaluate the efficacy of the Am smartphone-app for treating symptoms of anxiety, sleep disturbance, mood disturbance, and overall quality of life

    PROMIS57 is a collection of short forms containing a fixed number of items from seven PROMIS domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). There are 8 questions per domain, and an additional pain intensity 0-10 numeric rating scale (NRS). The Profiles are universal rather than disease-specific.

    Measured: 6 months

  3. Outcome: clinician reported quality of patient appointment time; measure: purpose designed survey questions

    Survey 1

    1. How has this patient's mental health impacted the quality of time spent during your appointments with them to-date?
    2. Have you had to make last minute changes to your care plan for this patient depending on their mental state when they have come to attend appointments?

    Survey 2

    1. How has the quality of time spent during your appointments with this patient has changed over the last 4 weeks?
    2. Over the last 4 weeks, how has this patient's mental health impacted the quality of time spent during your appointments with them?
    3. Over the last 4 weeks, have you had to make last minute changes to your care plan for this patient depending on their mental state when they have come to attend appointments?

    Measured: 1 month

  4. Outcome: Mood; Measure: The Am app's mood measure

    Am quantifies the efficacy of mindfulness training on each individual user through self-reports.

    Self-reported mood will be collected by the participant's selection of mood words from Mobio's circumplex model of affect (based on Posner, Russell \& Peterson, 2005). This model holds that all emotions derive from two underlying, orthogonal dimensions of emotional experience: valence and arousal. These orthogonal dimensions divide the circumplex into four quarters: low arousal - low affect; low arousal - high affect; high arousal - low affect; high arousal - high affect.

    Measured: 6 months

  5. Outcome: Psychological flexibility; Measure: The Acceptance & Action Questionnaire-II

    The Acceptance \& Action Questionnaire-II (AAQ-II) was developed in order to measure psychological flexibility, and scores have been found to predict many outcomes, including mental health and work absence rates.

    The AAQ-II is a seven item, one factor measure of psychological inflexibility or experiential avoidance. The scale is scored by summing the responses. Higher scores equal greater levels of psychological inflexibility.

    Measured: 6 months

  6. Outcome: User engagement; Measure: The Am app's user analytics - meditation choice and frequency

    The time, date and type of meditation users choose while participating in the study.

    Measured: 6 months

  7. Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (Heart Rate)

    Am quantifies the efficacy of mindfulness training on each individual user through heart rate, an objective assessment of stress made possible through computer vision (biometrics) with the mobile device camera.

    Measured: 6 months

  8. Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (respiratory rate)

    Am quantifies the efficacy of mindfulness training on each individual user through respiratory rate, an objective assessment of stress made possible through computer vision (biometrics) with the mobile device camera.

    Measured: 6 months

  9. Outcome: Mood, stress and heart rate; Measure: The Am app's biometric measures (relative blood oxygen saturation)

    Am quantifies the efficacy of mindfulness training on each individual user through relative blood oxygen saturation, an objective assessment of stress made possible through computer vision (biometrics) with the mobile device camera.

    Measured: 6 months

  10. Outcome: Stress; Measure: The Am app's stress measure

    Am quantifies the efficacy of mindfulness training on each individual user through self-reports.

    Self-reported stress will be indicated by the participant's adjustment of a dynamic slider between the minimum score "no stress" and the maximum score "max stress" will be collected.

    Measured: 6 months

  11. Outcome: Stress; Measure: The Am app's intent for practicing mindfulness measure

    This will be based on the participants' indication as per their selection of between 1 and 3 "intent words". There are 24 options from which the participant can choose. These are divided into 6 outward intentions, and 18 inward intentions.

    Measured: 6 months

  12. Outcome: User engagement; Measure: The Am app's points structure

    Users are rewarded with in-app points according to a point structure that encourages engagement with the app.

    1. Page/screen views and dwell time.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2019
  2. Study start1 Apr 2019
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03908918
Sponsor's protocol ID
123
Status last verified
Dec 2019
First submitted
19 Mar 2019
Last updated
18 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sachs-Ericsson N, Van Orden K, Zarit S. Suicide and aging: special issue of Aging & Mental Health. Aging Ment Health. 2016;20(2):110-2. doi: 10.1080/13607863.2015.1099037. Epub 2015 Nov 7. No abstract available.

    PubMed 26548754

  • Schulze T, Maercker A, Horn AB. Mental health and multimorbidity: psychosocial adjustment as an important process for quality of life. Gerontology. 2014;60(3):249-54. doi: 10.1159/000358559. Epub 2014 Feb 28.

    PubMed 24603025

  • Rao KS, Chakraharti SK, Dongare VS, Chetana K, Ramirez CM, Koka PS, Deb KD. Antiaging Effects of an Intensive Mind and Body Therapeutic Program through Enhancement of Telomerase Activity and Adult Stem Cell Counts. J Stem Cells. 2015;10(2):107-25.

    PubMed 27125139

  • Scult M, Haime V, Jacquart J, Takahashi J, Moscowitz B, Webster A, Denninger JW, Mehta DH. A healthy aging program for older adults: effects on self-efficacy and morale. Adv Mind Body Med. 2015 Winter;29(1):26-33.

    PubMed 25607120

  • de Frias CM, Whyne E. Stress on health-related quality of life in older adults: the protective nature of mindfulness. Aging Ment Health. 2015;19(3):201-6. doi: 10.1080/13607863.2014.924090. Epub 2014 Jun 18.

    PubMed 24940847

  • Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018.

    PubMed 24395196

  • Charness N, Best R, Evans J. Supportive home health care technology for older adults: Attitudes and implementation. Gerontechnology. 2016 Feb 23;15(4):233-242. doi: 10.4017/gt.2016.15.4.006.00.

    PubMed 29033700

  • Deng Z, Mo X, Liu S. Comparison of the middle-aged and older users' adoption of mobile health services in China. Int J Med Inform. 2014 Mar;83(3):210-24. doi: 10.1016/j.ijmedinf.2013.12.002. Epub 2013 Dec 16.

    PubMed 24388129

  • Nguyen T, Irizarry C, Garrett R, Downing A. Access to mobile communications by older people. Australas J Ageing. 2015 Jun;34(2):E7-E12. doi: 10.1111/ajag.12149. Epub 2014 Apr 17.

    PubMed 24750499

  • Walsh KM, Saab BJ, Farb NA. Effects of a Mindfulness Meditation App on Subjective Well-Being: Active Randomized Controlled Trial and Experience Sampling Study. JMIR Ment Health. 2019 Jan 8;6(1):e10844. doi: 10.2196/10844.

    PubMed 30622094

  • Hill J, McVay JM, Walter-Ginzburg A, Mills CS, Lewis J, Lewis BE, Fillit H. Validation of a brief screen for cognitive impairment (BSCI) administered by telephone for use in the medicare population. Dis Manag. 2005 Aug;8(4):223-34. doi: 10.1089/dis.2005.8.223.

    PubMed 16117717

  • van den Brink M, van den Hout WB, Stiggelbout AM, Putter H, van de Velde CJ, Kievit J. Self-reports of health-care utilization: diary or questionnaire? Int J Technol Assess Health Care. 2005 Summer;21(3):298-304. doi: 10.1017/s0266462305050397.

    PubMed 16110708

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness app in people with Psychological Stress and Psychological Distress, run by Providence Healthcare 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 6 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 18 Dec 2019. 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?

Outcome: Cost of treatment; Measure: Duration of stay (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03908918, which also lists 12 linked publications.

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 18 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in