Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2020-08-12
2021-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Smartphone app
All participants in this single-arm study will receive two months of subsidized, full access to the smartphone wellness application.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Washington University School of Medicine
St Louis, Missouri, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Ruoff GE. Depression in the patient with chronic pain. J Fam Pract. 1996 Dec;43(6 Suppl):S25-33; discussion S34.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202005219
Identifier Type: -
Identifier Source: org_study_id