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

Not Applicable

• Conditions: Pain, Postoperative; Analgesics, Opioid
• Interventions: Device: InCaveo's EOA system with integrated mobile CBT

• Registration Number: NCT04836169
• Lead Sponsor: InCaveo

Brief Summary

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.

Detailed Description

The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy (CBT) built into a mobile software app, patient medication usage, and tracking of patient PROs. It is designed to be used alongside Usual Standard of Care using Pill Bottles or to simplify, Usual Care with Pill Bottles (UCPB) treatment practices. The InCaveo EOA System is designed to improve a set of patient outcome measures, primarily Pain Catastrophizing Scale (PCS) and secondarily the Visual Numeric Pain (VNS), Kinesiophobia (TSK) and satisfaction scores while facilitating the ability of patients to taper off their pain medication faster than through the use of USPB in the management of post-operative pain. In order to reduce confounding variables, the study will focus on pain management following a single surgical procedure: Total Knee Replacement (TKR) surgery.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-05
• Last Update Submitted: 2021-04-05
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Study Start: 2021-10
• Primary Completion: 2022-04
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patient has a Pain Catastrophizing Score >16
2. 55 years of age and older.
3. English speaking.
4. Has a smartphone (iPhone).
5. Able to swallow oral medications.
6. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery.
7. Undergoing TKR surgery.
8. Patients who are willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria

1. Diagnosed with Opioid Use Disorder (OUD).
2. Actively using illicit drugs.
3. Allergy to opioids
4. Older than 85 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
InCaveo EOA System	InCaveo's EOA system with integrated mobile CBT	InCaveo EOA System (including integrated CBT but without tapering) group

Primary Outcome Measures

Name	Time	Method
Pain Catastrophizing Scale (PCS)	60 days	A measure of the extent of catastrophizing