Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wellness Through Mobile Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640090
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Musculoskeletal Diseases Chronic Pain Anxiety Disorders Depression Behavioral: Smartphone app (Wysa) Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 12, 2020
Actual Primary Completion Date : September 14, 2021
Actual Study Completion Date : September 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640090


Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04640090    
Other Study ID Numbers: 202005219
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not have plans to share IPD from this pilot study. Requests for IPD will be considered on a case-by-case basis.

Layout table for additional information
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:
Musculoskeletal disease
Chronic pain
Behavioral health
Anxiety
 Depression
Mobile health
Smartphone application
Additional relevant MeSH terms:
Layout table for MeSH terms
Musculoskeletal Diseases
Chronic Pain
Depression
Anxiety Disorders
 Behavioral Symptoms
Mental Disorders
Pain
Neurologic Manifestations