Wellness Through Mobile Health

Not Applicable

Completed

• Conditions: Chronic Pain; Anxiety Disorders; Depression; Musculoskeletal Diseases
• Interventions: Behavioral: Smartphone app (Wysa)

• Registration Number: NCT04640090
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-08-12
• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-23
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-14
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smartphone app	Smartphone app (Wysa)	All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.

Primary Outcome Measures

Name	Time	Method
Mean change in depression symptoms	2 months	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores
Mean change in anxiety symptoms	2 months	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States