Optimizing Mental Health in Orthopedic Care

February 13, 2026 updated by: Abby Cheng, Washington University School of Medicine

Optimizing Implementation of Mental Health Intervention Within Orthopedic Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression and anxiety heighten musculoskeletal pain and negatively impact outcomes after orthopedic surgery. This phenomenon is especially prevalent in older adults. Our ongoing pilot work demonstrates promise that an established digital mental health intervention (Wysa) can improve orthopedic patients' mental health symptoms, but we also encountered implementation barriers related to discussing mental health in an orthopedic setting. The long-term goal of this line of research is to enable the provision of true comprehensive care to improve both the physical and mental health of orthopedic patients. The goals of this project are to address the implementation barriers we encountered in our ongoing pilot work and to prepare for a definitive trial to assess the effectiveness of a digital mental health intervention in the context of orthopedic care.

The specific aims are to: 1.) identify the contextual determinants of implementation success for addressing patients' mental health in the context of orthopedic care; 2.) conduct usability testing for two mental health interventions which can feasibly be implemented in a real-world orthopedic setting: a digital mental health intervention (Wysa) and a novel printed resource guide; and 3.) identify the intermediate mechanisms through which a digital mental health intervention (Wysa) improves mental health symptoms in orthopedic patients.

Using standard qualitative methods and guided by the Consolidated Framework for Implementation Research (CFIR) and the COM-B model of behavior change, two stakeholder groups will be interviewed: orthopedic providers and older adult orthopedic spine patients. In addition to addressing specific needs and preferences related to discussing mental health in the setting of orthopedic care, patient stakeholders will complete usability testing of Wysa and of the novel printed guide of local and online mental health resources. Next, the patient stakeholders will receive one month of access to Wysa. They will complete measures of clinical effectiveness (self-reported depression, anxiety, pain interference, physical function) and hypothesized behavioral targets (behavioral activation, pain acceptance, sleep quality) at baseline and one-month follow-up. The study findings will facilitate design of a subsequent clinical effectiveness trial that is designed for equitable dissemination and effective implementation of mental health intervention within the context of orthopedic care.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orthopedic spine patients
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult PROMIS CAT Depression v1.0
Time Frame: Change in score from baseline to post-treatment (Month 1)
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
Time Frame: Change in score from baseline to post-treatment (Month 1)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adult PROMIS CAT Pain Interference v1.1
Time Frame: Change in score from baseline to post-treatment (Month 1)
The PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference measure is a brief, computer-adapted measure of how much pain interferes with a person's life. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent increased pain interference.
Change in score from baseline to post-treatment (Month 1)
Adult PROMIS CAT Physical Function v2.0
Time Frame: Change in score from baseline to post-treatment (Month 1)
The PROMIS (Patient-Reported Outcomes Measurement Information System) Physical Function measure is a brief, computer-adapted measure of a person's self-reported physical functioning. It is a normalized measure with a mean of 50 and standard deviation of 10. Higher scores represent better physical functioning.
Change in score from baseline to post-treatment (Month 1)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral Activation for Depression Scale - Short Form (BADS-SF)
Time Frame: Change in score from baseline to post-treatment (Month 1)
The BADS-SF is a nine-item, self-report measure of behavioral activation (i.e., engagement in activities that bring a sense of enjoyment). The measure is scored from 0 to 54, with higher scores representing higher activation.
Change in score from baseline to post-treatment (Month 1)
Chronic Pain Acceptance Questionnaire (CPAQ-8)
Time Frame: Change in score from baseline to post-treatment (Month 1)
The CPAQ-8 is an eight-item, self-report measure of pain acceptance (i.e., the thought pattern of living life despite pain, rather than focusing on the presence of pain). The measure is scored from 0 to 48, with higher scores representing greater pain acceptance.
Change in score from baseline to post-treatment (Month 1)
Athens Insomnia Scale (AIS)
Time Frame: Change in score from baseline to post-treatment (Month 1)
The AIS is an eight-item, self-report measure of insomnia severity. It evaluates multiple sleep domains including sleep duration, disruptions, quality, and interference with daily functioning caused by poor sleep. The measure is scored from 0 to 24, with higher scores representing greater sleep difficulty.
Change in score from baseline to post-treatment (Month 1)
System Usability Scale (SUS)
Time Frame: Change in score from baseline to post-treatment (Month 1)
The SUS is a brief measure of usability, which can be adapted to both digital and printed interventions. The measure is scored from 0 to 100, with higher scores representing better usability.
Change in score from baseline to post-treatment (Month 1)
Engagement content
Time Frame: Month 1
The engagement content is defined as the number of sessions that were initiated by the user within the time frame of interest and were related to each of the following categories: behavioral activation, mindfulness, and/or sleep tools.
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Abby Cheng, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

June 18, 2022

Study Completion (Actual)

June 18, 2022

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202110165
  • P50MH122351 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared due to the pilot nature of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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