Wellness Through Mobile Health

NCT04640090 | Completed

• 1 other identifier: 202005219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Musculoskeletal Diseases; Chronic Pain; Anxiety Disorders; Depression

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean change in anxiety symptoms

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

  2 months

• Mean change in depression symptoms

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

  2 months

Secondary Outcomes (5)

• Mean change in anxiety symptoms

  1 month

• Mean change in depression symptoms

  1 month

• Mean change in physical function symptoms

  1 month and 2 months

• Mean change in pain interference symptoms

  1 month and 2 months

• Frequency of app usage

  1 month and 2 months

Study Arms (1)

Smartphone app

EXPERIMENTAL

All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.

Behavioral: Smartphone app (Wysa)

Interventions

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.

Smartphone app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (20)

• 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.

  PMID: 28706741 BACKGROUND

• 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.

  PMID: 9669787 BACKGROUND

• 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.

  PMID: 30212442 BACKGROUND

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

  PMID: 8969710 BACKGROUND

• 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.

  PMID: 28271080 BACKGROUND

• 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.

  PMID: 23931656 BACKGROUND

• 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.

  PMID: 28703947 BACKGROUND

• 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.

  PMID: 30470676 BACKGROUND

• 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.

  PMID: 25138978 BACKGROUND

• 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.

  PMID: 28501708 BACKGROUND

• 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.

  PMID: 19836622 BACKGROUND

• 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.

  PMID: 14609780 BACKGROUND

• 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.

  PMID: 20353408 BACKGROUND

• 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.

  PMID: 20002592 BACKGROUND

• 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.

  PMID: 25816044 BACKGROUND

• Foraker RE, Kite B, Kelley MM, Lai AM, Roth C, Lopetegui MA, Shoben AB, Langan M, Rutledge NL, Payne PR. EHR-based Visualization Tool: Adoption Rates, Satisfaction, and Patient Outcomes. EGEMS (Wash DC). 2015 Jun 18;3(2):1159. doi: 10.13063/2327-9214.1159. eCollection 2015.

  PMID: 26290891 BACKGROUND

• Kretzschmar K, Tyroll H, Pavarini G, Manzini A, Singh I; NeurOx Young People's Advisory Group. Can Your Phone Be Your Therapist? Young People's Ethical Perspectives on the Use of Fully Automated Conversational Agents (Chatbots) in Mental Health Support. Biomed Inform Insights. 2019 Mar 5;11:1178222619829083. doi: 10.1177/1178222619829083. eCollection 2019.

  PMID: 30858710 BACKGROUND

• Soons P, Denollet J. Medical psychology services in dutch general hospitals: state of the art developments and recommendations for the future. J Clin Psychol Med Settings. 2009 Jun;16(2):161-8. doi: 10.1007/s10880-009-9158-7. Epub 2009 Mar 6.

  PMID: 19266269 BACKGROUND

• Sinha C, Cheng AL, Kadaba M. Adherence and Engagement With a Cognitive Behavioral Therapy-Based Conversational Agent (Wysa for Chronic Pain) Among Adults With Chronic Pain: Survival Analysis. JMIR Form Res. 2022 May 23;6(5):e37302. doi: 10.2196/37302.

  PMID: 35526201 DERIVED

• Leo AJ, Schuelke MJ, Hunt DM, Metzler JP, Miller JP, Arean PA, Armbrecht MA, Cheng AL. A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study. JMIR Form Res. 2022 Feb 21;6(2):e34889. doi: 10.2196/34889.

  PMID: 35039278 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Chronic Pain; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 23, 2020
• Study Start: August 12, 2020
• Primary Completion: September 14, 2021
• Study Completion: September 14, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)