NCT05812703

Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain

What Objective Changes Occur With Behavioral Treatment: Evaluating Biometrics and Self -Reported Health Measures of Adult Patients Receiving Behavioral Treatments With Chronic Pain

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will provide important information regarding the biometric changes that occur in behavioral treatments for chronic pain and explore the additional impact of integrated movement and supervised exercise. The goal of this clinical trial is to determine if pain rehabilitation programs have impacts on physical function in patient reported outcomes and objective measures of physical activity or sedentary time with a wearable Fitbit. Additionally, we will examine the associations between movement, pain acceptance, and related health factors, such as pain severity, sleep, functional status, depression, and anxiety. The addition of biometric data will allow for further investigation of the association between objective measures and patient self-report measures.

Detailed description

Chronic pain has high impact on societal function as well as an individual person's mood, physical function, disability, and quality of life and their health. The purpose of the study is to collect objective outcome measures on movement, activity, biometrics and patient reported outcome measures for participants of behavioral treatment groups of 6-8 weeks duration at Stanford Pain Management Center. Group participants learn skills and develop a personalized plan to use the skills throughout the program. The study will follow participants with a removable wearable device on the wrist for 2 weeks pre group to establish movement activity baselines, during the group intervention (6-8 weeks) and 2 weeks post group to determine which groups have benefits across various aspects of health including: sleep, psychological processes of pain acceptance, physical mobility, quality of life and the impact of supervised movement and physical activity in the treatment groups.

Conditions

• Chronic Pain
• Sedentary Time

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	The participants will attend one of the behavioral group treatments programs offered by the Stanford Pain Management Center. This class may be held online via Zoom, or in person based at the Stanford Pain Management Center. The class may be recorded for training purposes. No names or images/faces will be recorded for privacy reasons. The behavioral groups are 3 types, with or without exercise/movement. Current Evidence Based treatments that are provided as standard practice include: Cognitive Behavioral Therapy Group, with movement, Acceptance and Commitment Therapy Group, with or without movement. Group participants will learn different skills in each group and develop a personalized plan to use the skills after group ends. At the end of group participants will be given an anonymous survey about the class to evaluate satisfaction of the treatment. Movement in this portion of class is designed to low impact and restorative/gentle, with no significant increases in HR \> 50% HRmax.
BEHAVIORAL	Acceptance and Commitment Therapy (ACT)	ACT is a 6 week behavioral group program led by a psychologist to improve psychological flexibility and reduce pain interference in patients with chronic pain.
BEHAVIORAL	Moderate to high Intensity Group Exercise	Group exercise led by supervised clinician with Cardiovascular focus to increase HR into zones to see adaptations to improve cardiovascular fitness.

Timeline

• Start date: 2024-09-27
• Primary completion: 2025-10-25
• Completion: 2026-04-25
• First posted: 2023-04-14
• Last updated: 2024-05-07

Locations

1 site across 1 country: United States