Optimizing Mental Health in Orthopedic Care

Depression Clinical Trial

Official title:

Optimizing Implementation of Mental Health Intervention Within Orthopedic Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194722
• Other study ID #: 202110165
• Secondary ID: P50MH122351
• Status: Completed
• Phase: N/A
• Start date: January 6, 2022
• Est. completion date: June 18, 2022

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 18, 2022
• Est. primary completion date: June 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Back Pain
• Depression
• Neck Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Adult PROMIS CAT Pain Interference v1.1	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)
Secondary	Adult PROMIS CAT Physical Function v2.0	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)