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

NCT ID: NCT03908918

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psychological Stress Psychological Distress Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active group

Mobile-app delivered mindfulness intervention. Dosage: 4 times per week for 4 weeks

Group Type EXPERIMENTAL

Mindfulness app

Intervention Type OTHER

Mobile app-delivered mindfulness intervention delivered over 4 weeks.

Waitlist control

Waitlist control - receiving the app after 6 months

Group Type OTHER

Mindfulness app

Intervention Type OTHER

Mobile app-delivered mindfulness intervention delivered over 4 weeks.

Interventions

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Mindfulness app

Mobile app-delivered mindfulness intervention delivered over 4 weeks.

Intervention Type OTHER

Other Intervention Names

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Am

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Providence Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Rachel Devitt

Professional Practice Leader, Occupational Therapy and Manager, Clinical Research at Providence Healthcare

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Devitt

Role: PRINCIPAL_INVESTIGATOR

Providence Healthcare

Locations

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Providence Healthcare

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 26548754 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24603025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27125139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25607120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24940847 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24395196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29033700 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24388129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24750499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30622094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16117717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16110708 (View on PubMed)

Other Identifiers

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123

Identifier Type: -

Identifier Source: org_study_id