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Completed

NCT Number: NCT04640090

Wellness Through Mobile Health

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone app (Wysa)

Behavioral

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 outcomes

  1. Mean change in anxiety symptoms

    Time frame: 2 months

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

  2. Mean change in depression symptoms

    Time frame: 2 months

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

Secondary outcomes

  1. Mean change in anxiety symptoms

    Time frame: 1 month

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

  2. Mean change in depression symptoms

    Time frame: 1 month

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

  3. 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

  4. 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

  5. Frequency of app usage

    Time frame: 1 month and 2 months

    Self-reported average weekly usage of the smartphone app

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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