Clinical trial NCT04640090: Wellness Through Mobile Health
Official title: Effectiveness of a Smartphone Wellness App to Improve Mental Well-being: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Chronic Pain
Anxiety Disorders
Depression
Keywords: Musculoskeletal disease
Chronic pain
Behavioral health
Anxiety
Depression
Mobile health
Smartphone application
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-11-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean change in anxiety symptoms
timeFrame: 2 months
measure: Mean change in depression symptoms
timeFrame: 2 months
Secondary outcomes:
measure: Mean change in anxiety symptoms
timeFrame: 1 month
measure: Mean change in depression symptoms
timeFrame: 1 month
measure: Mean change in physical function symptoms
timeFrame: 1 month and 2 months
measure: Mean change in pain interference symptoms
timeFrame: 1 month and 2 months
measure: Frequency of app usage
timeFrame: 1 month and 2 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
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