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Orthopedic spine patients for Neck Pain

N/A
Waitlist Available
Led By Abby Cheng, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1
Awards & highlights

Study 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.

Eligible Conditions
  • Neck Pain
  • Depression
  • Anxiety
  • Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adult PROMIS CAT Anxiety v1.0
Adult PROMIS CAT Depression v1.0
Secondary outcome measures
Adult PROMIS CAT Pain Interference v1.1
Adult PROMIS CAT Physical Function v2.0
Other outcome measures
Athens Insomnia Scale (AIS)
Behavioral Activation for Depression Scale - Short Form (BADS-SF)
Chronic Pain Acceptance Questionnaire (CPAQ-8)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Orthopedic spine patientsExperimental Treatment1 Intervention
In addition to participating in semi-structured interviews and usability testing of the study interventions, participants in this arm will receive one month of access to Wysa. They will complete measures of clinical effectiveness and hypothesized behavioral targets at baseline and one-month follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Wysa mobile app
2022
N/A
~30

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,689,245 Total Patients Enrolled
Washington University Center for Perioperative Mental HealthUNKNOWN
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,843 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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~9 spots leftby Apr 2025
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