Wellness Through Mobile Health

Study Overview
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Brief Summary
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This pilot project will evaluate the potential of an affordable smartphone app to improve users' mental well-being.

Detailed Description
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The goal of this pilot study is to evaluate whether a smartphone wellness application has the potential to improve anxiety and depression symptoms in people who otherwise would not have access to behavioral health care. In this pilot study, participants will include patients who present to an orthopedic specialist for chronic musculoskeletal pain and who also endorse elevated anxiety and/or depression symptoms. Patients who otherwise do not have access to adequate behavioral health resources will be eligible to enroll in the study. Through the study, participants will have two months of full access to a commercially available smartphone wellness application which offers resources such as cognitive behavioral therapy via an artificial chatbot, mindfulness and deep breathing training, and text-based access to a human well-being coach. Participants' baseline and 2-month follow-up anxiety and depression symptoms will be compared. Qualitative feedback regarding the user experience with the smartphone application will also be collected.

Official Title
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Effectiveness of a Smartphone Wellness App to Improve Mental Well-being: A Pilot Study

Conditions
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Musculoskeletal Diseases, Chronic Pain, Anxiety Disorders, Depression

Intervention / Treatment
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* Behavioral: Smartphone app (Wysa)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presentation to an orthopedic specialist at the Washington University Living Well Center for a musculoskeletal condition Score of 55 or higher on Patient-Reported Outcomes Measurement Information System (PROMIS) Depression and/or Anxiety measures Advised to consider behavioral health treatment as a component of comprehensive care for a musculoskeletal condition Cannot or does not wish to pursue in-person behavioral health treatment (e.g., with the center psychologist) Exclusion Criteria: No access to an electronic device (such as a smartphone) to download and use the wellness app and to electronically complete follow-up self-reported health measures In active mental health crisis (e.g., suicidal/homicidal thoughts, psychosis) which would require an escalated level of care Initiating care with a behavioral health specialist

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone app<br>All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application. | Behavioral: Smartphone app (Wysa)<br>* The commercially available smartphone application, Wysa, offers evidence-based wellness tools such as supportive listening, deep breathing techniques, guided meditation, yoga, and more. Users can communicate via text to a virtual artificial intelligence (AI) chatbot and/or a human well-being coach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in anxiety symptoms | Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores | 2 months | 
| Mean change in depression symptoms | Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in anxiety symptoms | Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores | 1 month | 
| Mean change in depression symptoms | Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores | 1 month | 
| Mean change in physical function symptoms | Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores | 1 month and 2 months | 
| Mean change in pain interference symptoms | Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores | 1 month and 2 months | 
| Frequency of app usage | Self-reported average weekly usage of the smartphone app | 1 month and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musculoskeletal disease, Chronic pain, Behavioral health, Anxiety, Depression, Mobile health, Smartphone application