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Wellness Through Mobile Health

Primary Purpose

Musculoskeletal Diseases, Chronic Pain, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smartphone app (Wysa)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases focused on measuring Musculoskeletal disease, Chronic pain, Behavioral health, Anxiety, Depression, Mobile health, Smartphone application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Smartphone app

Arm Description

All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2020
Last Updated
November 29, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04640090
Brief Title
Wellness Through Mobile Health
Official Title
Effectiveness of a Smartphone Wellness App to Improve Mental Well-being: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
September 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases, Chronic Pain, Anxiety Disorders, Depression
Keywords
Musculoskeletal disease, Chronic pain, Behavioral health, Anxiety, Depression, Mobile health, Smartphone application

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone app
Arm Type
Experimental
Arm Description
All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone app (Wysa)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in anxiety symptoms
Description
Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores
Time Frame
2 months
Title
Mean change in depression symptoms
Description
Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Mean change in anxiety symptoms
Description
Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores
Time Frame
1 month
Title
Mean change in depression symptoms
Description
Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores
Time Frame
1 month
Title
Mean change in physical function symptoms
Description
Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores
Time Frame
1 month and 2 months
Title
Mean change in pain interference symptoms
Description
Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
Time Frame
1 month and 2 months
Title
Frequency of app usage
Description
Self-reported average weekly usage of the smartphone app
Time Frame
1 month and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not have plans to share IPD from this pilot study. Requests for IPD will be considered on a case-by-case basis.
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Wellness Through Mobile Health

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