Wellness Through Mobile Health

November 29, 2021 updated by: Washington University School of Medicine

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone app
All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.
Behavioral: Smartphone app (Wysa)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Actual)

September 14, 2021

Study Completion (Actual)

September 14, 2021

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 29, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202005219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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