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

Providence Healthcare

Status: Completed

Conditions: Rehabilitation; Psychological Stress; Psychological Distress

Treatments: Other: Mindfulness app

Study type: Interventional

Funder types: Other

Identifiers

NCT03908918

123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Active group

Experimental group

Description:

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

Treatment:

Other: Mindfulness app

Waitlist control

Other group

Description:

Waitlist control - receiving the app after 6 months

Treatment:

Other: Mindfulness app