Optimizing Mental Health in Orthopedic Care

Sponsor

Washington University School of Medicine (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05194722

Collaborator

National Institute of Mental Health (NIMH) (NIH), Washington University Center for Perioperative Mental Health (Other)

Enrollment

Location

Arm

7.8

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Back Pain Neck Pain	Behavioral: Wysa mobile app	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optimizing Implementation of Mental Health Intervention Within Orthopedic Care

Actual Study Start Date :

Jan 6, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orthopedic spine patients ≥ 65 years old Group 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.

Arm

Intervention/Treatment

Experimental: Orthopedic spine patients ≥ 65 years old Group

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.

Outcome Measures

Primary Outcome Measures

Adult PROMIS CAT Depression v1.0 [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.
Adult PROMIS CAT Anxiety v1.0 [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.

Secondary Outcome Measures

Adult PROMIS CAT Pain Interference v1.1 [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.
Adult PROMIS CAT Physical Function v2.0 [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.

Other Outcome Measures

Behavioral Activation for Depression Scale - Short Form (BADS-SF) [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.
Chronic Pain Acceptance Questionnaire (CPAQ-8) [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.
Athens Insomnia Scale (AIS) [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.
System Usability Scale (SUS) [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.
Engagement content [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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