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

Study Overview
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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.

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

Conditions
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Psychological Stress, Psychological Distress, Rehabilitation

Intervention / Treatment
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* Other: Mindfulness app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active group<br>Mobile-app delivered mindfulness intervention. Dosage: 4 times per week for 4 weeks | Other: Mindfulness app<br>* Mobile app-delivered mindfulness intervention delivered over 4 weeks.<br>* Other names: Am;|
| Other: Waitlist control<br>Waitlist control - receiving the app after 6 months | Other: Mindfulness app<br>* Mobile app-delivered mindfulness intervention delivered over 4 weeks.<br>* Other names: Am;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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). 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 How many times did you visit your doctor's office visits in the last 3 months? How many times a caregiver visit you in your home in the last 3 months? How many times were you admitted to a hospital in the last 3 months. | 6 months | 
| 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). | 6 months | 
| 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 | 6 months | 
| 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. - Total assistance with helper - Maximal assistance with helper - Moderate assistance with helper - Minimal assistance with helper - Supervision or setup with helper - Modified independence with no helper - Complete independence with no helper | 6 months | 
| 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. | 6 months | 
| Outcome: Cost of treatment; Measure: number of clinic visits | Post six-month retrospective report of patients' clinic visits. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| 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. | 6 months | 
| Outcome: clinician reported quality of patient appointment time; measure: purpose designed survey questions | Survey 1 How has this patient's mental health impacted the quality of time spent during your appointments with them to-date? 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 How has the quality of time spent during your appointments with this patient has changed over the last 4 weeks? Over the last 4 weeks, how has this patient's mental health impacted the quality of time spent during your appointments with them? 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? | 1 month | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. | 6 months | 
| 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. 3. Page/screen views and dwell time. | 6 months |