N/A
N=30
Optimizing Mental Health in Orthopedic Care
Anxiety · Depression · Back Pain · Neck Pain
Bottom Line
View on ClinicalTrials.gov: NCT05194722 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Adult PROMIS CAT Depression v1.0 — -1.3 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Wysa mobile app (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adult PROMIS CAT Depression v1.0 |
-1.3 | — |
| PRIMARY Adult PROMIS CAT Anxiety v1.0 |
-3.2 | — |
| SECONDARY Adult PROMIS CAT Pain Interference v1.1 |
-3.5 | — |
| SECONDARY Adult PROMIS CAT Physical Function v2.0 |
1.4 | — |
Summary
This study will utilize qualitative cross-sectional and quantitative longitudinal methods. In semi-structured interviews, orthopedic providers and patients with spine conditions will discuss their overall perspectives, specific needs, and preferred solutions to addressing mental health impairment in the context of orthopedic care and research. In these sessions, patient stakeholders will also user test two specific mental health interventions: a customized version of a commercial digital mental health intervention (Wysa) and a prototype of a print-based mental health resource guide. The patient stakeholders will be provided one month of Wysa access, and they will complete baseline and follow-up measures related to usability, clinical effectiveness, and intermediate behavioral mechanisms through which Wysa is hypothesized to act. Wysa usage data will be obtained from the app company. Delivery of Wysa and the printed resource guide will be iteratively refined based on user feedback.
Eligibility Criteria
Inclusion criteria
- Orthopedic patient presenting for outpatient clinic evaluation to a spine specialist for neck and/or back pain
- Musculoskeletal spine pain for 3+ months
Exclusion criteria
- Routine post-operative visit with no plans for further surgery
- Endorses mental health crisis (active suicidal or homicidal ideation, psychosis)
- Cognitive impairment which would interfere with meaningful engagement with research interview, questionnaires, and/or intervention
Data sourced from ClinicalTrials.gov (NCT05194722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.