Anxiety, Back Pain, Depression, Neck Pain
Conditions
Keywords
Anxiety, Depression, Spine, Chronic pain, Digital mental health intervention, Orthopedics
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.
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.
Interventions
BEHAVIORALWysa 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.
Sponsors
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAbby Cheng, MD
Washington University School of Medicine
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Orthopedic Spine Patients |
|---|---|
| Adult PROMIS CAT Anxiety v1.0 | 59.1 Points STANDARD_DEVIATION 8.9 |
| Adult PROMIS CAT Depression v1.0 | 52.9 Points STANDARD_DEVIATION 8.7 |
| Adult PROMIS CAT Pain Interference v1.1 | 64.2 Points STANDARD_DEVIATION 7.2 |
| Adult PROMIS CAT Physical Function v2.0 | 38.6 Points STANDARD_DEVIATION 7.2 |
| Age, Continuous | 59 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex/Gender, Customized Sex Female | 21 Participants |
| Sex/Gender, Customized Sex Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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.
Time frame: Change in score from baseline to post-treatment (Month 1)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Orthopedic Spine Patients | Adult PROMIS CAT Anxiety v1.0 | -3.2 T-score |
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.
Time frame: Change in score from baseline to post-treatment (Month 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Orthopedic Spine Patients | Adult PROMIS CAT Depression v1.0 | -1.3 T-score |
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.
Time frame: Change in score from baseline to post-treatment (Month 1)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Orthopedic Spine Patients | Adult PROMIS CAT Pain Interference v1.1 | -3.5 T-score |
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.
Time frame: Change in score from baseline to post-treatment (Month 1)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Orthopedic Spine Patients | Adult PROMIS CAT Physical Function v2.0 | 1.4 T-score |