Optimizing Mental Health in Orthopedic Care

NCT05194722 | Completed Results

• 2 other identifiers: 202110165P50MH122351
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Depression; Back Pain; Neck Pain

Keywords

Anxiety; Depression; Spine; Chronic pain; Digital mental health intervention; Orthopedics

Outcome Measures

Primary Outcomes (2)

• Adult PROMIS CAT Depression v1.0

  The PROMIS (Patient-Reported Outcomes Measurement Information System) Depression measure is a brief, computer-adapted measure of depression symptoms. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased depression symptoms.

  Change in score from baseline to post-treatment (Month 1)

• Adult PROMIS CAT Anxiety v1.0

  The PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety measure is a brief, computer-adapted measure of anxiety symptoms. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased anxiety symptoms.

  Change in score from baseline to post-treatment (Month 1)

Secondary Outcomes (2)

• Adult PROMIS CAT Pain Interference v1.1

  Change in score from baseline to post-treatment (Month 1)

• Adult PROMIS CAT Physical Function v2.0

  Change in score from baseline to post-treatment (Month 1)

Study Arms (1)

Orthopedic spine patients

EXPERIMENTAL

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.

Behavioral: Wysa mobile app

Interventions

Wysa mobile app BEHAVIORAL

Wysa is a digital mental health intervention (i.e., mobile app) that uses an artificial intelligence based chatbot and text-based conversation with master's level human "coach" counselors to deliver cognitive behavioral therapy, mindfulness training, and sleep tools. In this study, a customized version of Wysa will be used which is specifically designed for users with coexisting chronic pain. The customized experience includes additional features based on behavioral activation. This version is not currently commercially available.

Orthopedic spine patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Orthopedic patient presenting for outpatient clinic evaluation to a spine specialist for neck and/or back pain
• Musculoskeletal spine pain for 3+ months

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

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MeSH Terms

Conditions

Anxiety Disorders; Depression; Back Pain; Neck Pain; Chronic Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Abby Cheng, MD, PI
• Organization: Washington University School of Medicine

chengal@wustl.edu

314-747-2823

Study Officials

• Abby Cheng, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 18, 2022
• Study Start: January 6, 2022
• Primary Completion: June 18, 2022
• Study Completion: June 18, 2022
• Last Updated: February 17, 2026
• Results First Posted: November 9, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)