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Clinical Trials/NCT04640090
NCT04640090
Completed
N/A

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

Washington University School of Medicine1 site in 1 country60 target enrollmentAugust 12, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Musculoskeletal Diseases
Sponsor
Washington University School of Medicine
Enrollment
60
Locations
1
Primary Endpoint
Mean change in depression symptoms
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 12, 2020
End Date
September 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Mean change in depression symptoms

Time Frame: 2 months

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

Mean change in anxiety symptoms

Time Frame: 2 months

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

Secondary Outcomes

  • Mean change in depression symptoms(1 month)
  • Mean change in pain interference symptoms(1 month and 2 months)
  • Mean change in physical function symptoms(1 month and 2 months)
  • Frequency of app usage(1 month and 2 months)
  • Mean change in anxiety symptoms(1 month)

Study Sites (1)

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