Wellness Through Mobile Health

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04640090
Collaborator
(none)
60
1
1
13.1
4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smartphone app (Wysa)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of a Smartphone Wellness App to Improve Mental Well-being: A Pilot Study
Actual Study Start Date :
Aug 12, 2020
Actual Primary Completion Date :
Sep 14, 2021
Actual Study Completion Date :
Sep 14, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Mean change in anxiety symptoms [2 months]

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

  2. Mean change in depression symptoms [2 months]

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

Secondary Outcome Measures

  1. Mean change in anxiety symptoms [1 month]

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

  2. Mean change in depression symptoms [1 month]

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

  3. 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

  4. 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

  5. Frequency of app usage [1 month and 2 months]

    Self-reported average weekly usage of the smartphone app

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT04640090
Other Study ID Numbers:
  • 202005219
First Posted:
Nov 23, 2020
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021