Wellness Through Mobile Health

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640090
• Other study ID #: 202005219
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: September 14, 2021

Study information

• Verified date: November 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Chronic Pain
• Depression
• Musculoskeletal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Erratum in: JAMA 1998 Oct 7;280(13):1142. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in anxiety symptoms	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores	2 months
Primary	Mean change in depression symptoms	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores	2 months
Secondary	Mean change in anxiety symptoms	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety scores	1 month
Secondary	Mean change in depression symptoms	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression scores	1 month
Secondary	Mean change in physical function symptoms	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function scores	1 month and 2 months
Secondary	Mean change in pain interference symptoms	Mean longitudinal change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scores	1 month and 2 months
Secondary	Frequency of app usage	Self-reported average weekly usage of the smartphone app	1 month and 2 months