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Wellness Through Mobile Health

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04640090
Enrollment
60
Registered
2020-11-23
Start date
2020-08-12
Completion date
2021-09-14
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Chronic Pain, Depression, Musculoskeletal Diseases

Keywords

Musculoskeletal disease, Chronic pain, Behavioral health, Anxiety, Depression, Mobile health, Smartphone application

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.

Interventions

BEHAVIORALSmartphone 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Mean change in anxiety symptoms2 monthsMean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores
Mean change in depression symptoms2 monthsMean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores

Secondary

MeasureTime frameDescription
Mean change in physical function symptoms1 month and 2 monthsMean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores
Mean change in anxiety symptoms1 monthMean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores
Frequency of app usage1 month and 2 monthsSelf-reported average weekly usage of the smartphone app
Mean change in pain interference symptoms1 month and 2 monthsMean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores
Mean change in depression symptoms1 monthMean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026