Trials / Completed
CompletedNCT03353272
The Influence of a Cognitive Behavioral Approach on Changing Patient Expectations in Shoulder Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Background: Despite similar treatment outcomes for surgery or conservative care, the number of surgeries for the care of rotator cuff (RTC) related shoulder pain has increased. With the increase in surgery, there is an increased risk of harms, increased costs, and high re-tear rates. Patient expectations are beliefs or attitudes that include pre-treatment thoughts and beliefs regarding the need for specific treatment methods and the timing and intensity of these methods. Brief interventions designed to alter and enhance treatment expectations for conservative care and have been shown to improve patient expectations, but to date, no studies have explored whether such interventions can influence patient decisions to pursue surgical care. The investigators propose a comprehensive intervention that involves Patient Engagement Education, and Restructuring of Cognitions (PEERC) that is designed to change expectations, will reduce the likelihood that patients will choose to have shoulder surgery and improve functional outcomes. The cognitive behavioral therapy (CBT) approaches that form the core of our PEERC protocol are patient-centered and are designed to empower the patient in their own recovery process. Purpose/Aims: To examine the effect of the PEERC protocol on the decision to have surgery (primary), and improve global well-being, pain catastrophizing, pain, functional outcomes, and follow up expectations (secondary).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Patient Engagement Education and Restructuring of Cognitions | This protocol, informed by principles of CBT, involves three components: 1) engagement, 2) education and 3) cognitive restructuring and behavioral activation. A health coach who is responsible for engaging patients, educating them about pain modulatory mechanisms, and reinforcing cognitive and behavioral coping skills, will deliver the PEERC protocol. |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
- First posted
- 2017-11-27
- Last updated
- 2024-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03353272. Inclusion in this directory is not an endorsement.