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

Pain, Postoperative Clinical Trial

— P1RESPECT  

Official title:

Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy to Lower Pain Catastrophizing Scores

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04836169
• Other study ID #: InCaveoDanielandDaniel2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: May 2022

Study information

• Verified date: April 2021
• Source: InCaveo
• Contact: Cynthia Harris, BS
• Phone: 8326776747
• Email: cindy[@]clinregconsult.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesics, Opioid
• Pain, Postoperative

Intervention

Device:
• InCaveo's EOA system with integrated mobile CBT
integrated pain management therapeutic and tapering system including a software apt that manages and tracks patient-reported outcomes, including pain levels, medication use, quality of life

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
InCaveo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Catastrophizing Scale (PCS)	A measure of the extent of catastrophizing	60 days