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Musculoskeletal DiseasesNCT04640090

Wellness Through Mobile Health

A study testing Smartphone app (Wysa) in people with Musculoskeletal Diseases and Chronic Pain, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Smartphone app (Wysa)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
12 Aug 2020to 14 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Smartphone app (Wysa)
Keywords
Musculoskeletal disease, Chronic pain, Behavioral health, Anxiety, Depression, Mobile health, Smartphone application
Medical subject headings
Musculoskeletal Diseases, Chronic Pain, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smartphone app (Wysa)Behavioural

    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.

Study groups in NCT04640090
Study groupRoleWhat they receive
Smartphone appExperimentalAll participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.
Receives: Behavioral: Smartphone app (Wysa)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in anxiety symptoms

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

    Measured: 2 months

  2. Mean change in depression symptoms

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

    Measured: 2 months

Secondary outcomes (5)

  1. Mean change in anxiety symptoms

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

    Measured: 1 month

  2. Mean change in depression symptoms

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

    Measured: 1 month

  3. Mean change in physical function symptoms

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

    Measured: 1 month and 2 months

  4. Mean change in pain interference symptoms

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

    Measured: 1 month and 2 months

  5. Frequency of app usage

    Self-reported average weekly usage of the smartphone app

    Measured: 1 month and 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start12 Aug 2020
  3. Primary completion14 Sep 2021
  4. Study completion14 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640090
Sponsor's protocol ID
202005219
Status last verified
Nov 2021
First submitted
9 Nov 2020
Last updated
1 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not have plans to share IPD from this pilot study. Requests for IPD will be considered on a case-by-case basis.

Publications

  • Sheng J, Liu S, Wang Y, Cui R, Zhang X. The Link between Depression and Chronic Pain: Neural Mechanisms in the Brain. Neural Plast. 2017;2017:9724371. doi: 10.1155/2017/9724371. Epub 2017 Jun 19.

    PubMed 28706741

  • Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147.

    PubMed 9669787

  • Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2.

    PubMed 30212442

  • Ruoff GE. Depression in the patient with chronic pain. J Fam Pract. 1996 Dec;43(6 Suppl):S25-33; discussion S34.

    PubMed 8969710

  • Vranceanu AM, Beks RB, Guitton TG, Janssen SJ, Ring D. How do Orthopaedic Surgeons Address Psychological Aspects of Illness? Arch Bone Jt Surg. 2017 Jan;5(1):2-9.

    PubMed 28271080

  • Andrade LH, Alonso J, Mneimneh Z, Wells JE, Al-Hamzawi A, Borges G, Bromet E, Bruffaerts R, de Girolamo G, de Graaf R, Florescu S, Gureje O, Hinkov HR, Hu C, Huang Y, Hwang I, Jin R, Karam EG, Kovess-Masfety V, Levinson D, Matschinger H, O'Neill S, Posada-Villa J, Sagar R, Sampson NA, Sasu C, Stein DJ, Takeshima T, Viana MC, Xavier M, Kessler RC. Barriers to mental health treatment: results from the WHO World Mental Health surveys. Psychol Med. 2014 Apr;44(6):1303-17. doi: 10.1017/S0033291713001943. Epub 2013 Aug 9.

    PubMed 23931656

  • Kozloff N, Sommers BD. Insurance Coverage and Health Outcomes in Young Adults With Mental Illness Following the Affordable Care Act Dependent Coverage Expansion. J Clin Psychiatry. 2017 Jul;78(7):e821-e827. doi: 10.4088/JCP.16m11357.

    PubMed 28703947

  • Inkster B, Sarda S, Subramanian V. An Empathy-Driven, Conversational Artificial Intelligence Agent (Wysa) for Digital Mental Well-Being: Real-World Data Evaluation Mixed-Methods Study. JMIR Mhealth Uhealth. 2018 Nov 23;6(11):e12106. doi: 10.2196/12106.

    PubMed 30470676

  • Kroenke K, Yu Z, Wu J, Kean J, Monahan PO. Operating characteristics of PROMIS four-item depression and anxiety scales in primary care patients with chronic pain. Pain Med. 2014 Nov;15(11):1892-901. doi: 10.1111/pme.12537. Epub 2014 Aug 19.

    PubMed 25138978

  • Lee AC, Driban JB, Price LL, Harvey WF, Rodday AM, Wang C. Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis. J Pain. 2017 Sep;18(9):1096-1110. doi: 10.1016/j.jpain.2017.05.001. Epub 2017 May 10.

    PubMed 28501708

  • Gambassi G. Pain and depression: the egg and the chicken story revisited. Arch Gerontol Geriatr. 2009;49 Suppl 1:103-12. doi: 10.1016/j.archger.2009.09.018.

    PubMed 19836622

  • Bair MJ, Robinson RL, Katon W, Kroenke K. Depression and pain comorbidity: a literature review. Arch Intern Med. 2003 Nov 10;163(20):2433-45. doi: 10.1001/archinte.163.20.2433.

    PubMed 14609780

  • DeVeaugh-Geiss AM, West SL, Miller WC, Sleath B, Gaynes BN, Kroenke K. The adverse effects of comorbid pain on depression outcomes in primary care patients: results from the ARTIST trial. Pain Med. 2010 May;11(5):732-41. doi: 10.1111/j.1526-4637.2010.00830.x. Epub 2010 Mar 26.

    PubMed 20353408

  • Ang DC, Bair MJ, Damush TM, Wu J, Tu W, Kroenke K. Predictors of pain outcomes in patients with chronic musculoskeletal pain co-morbid with depression: results from a randomized controlled trial. Pain Med. 2010 Apr;11(4):482-91. doi: 10.1111/j.1526-4637.2009.00759.x. Epub 2009 Dec 9.

    PubMed 20002592

  • Weil TP. Insufficient dollars and qualified personnel to meet United States mental health needs. J Nerv Ment Dis. 2015 Apr;203(4):233-40. doi: 10.1097/NMD.0000000000000271.

    PubMed 25816044

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone app (Wysa) in people with Musculoskeletal Diseases and Chronic Pain, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in anxiety symptoms (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640090, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.

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