Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo\'s EOA system with integrated mobile CBT but without tapering to improve The Pain Catastrophizing Scale (PCS) scores, and secondarily scores on the VNS pain scale, the Tampa Scale of Kinesiophobia (TSK), and patient satisfaction scores in the subacute period (defined as 2 weeks to 3 months post TKR). Statistically significant positive results on the Pain Catastrophizing Scale (PCS) will trigger phase 2. Phase 1 will also inform the detailed conditions and patient management algorithms for Phase II.
Epistemonikos ID: 73ee44fef3cda8e8e9363aad910703ff2a390536
First added on: May 08, 2024