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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-27

Study Completion Date

2026-04-25

Brief Summary

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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.

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Detailed Description

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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

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Chronic Pain Sedentary Time

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Behavioral Group Treatment (Cognitive Behavioral Therapy CBT + Movement)

Cognitive Behavioral Therapy Group led by a psychologist to learn pain coping skills, with gentle movement component of duration from 45 minutes to 60 minutes under a licensed Healthcare provider (PT or OT).

Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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 Group Treatment (ACT) only

Acceptance and Commitment Therapy Group led by a psychologist to learn skills to change their relationship with pain to decrease pain's impact on their life.

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

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 Group Treatment (ACT + Movement)- Back in ACTion

Acceptance and Commitment Therapy Group led by a psychologist to learn skills to change their relationship with pain to decrease pain's impact on their life and improve willingness to engage in valued activities. Movement component to last from with intense and gentle movement sessions with a total movement time of 90 minutes - 2 hours led by licensed health care provider a PT or OT.

Acceptance and Commitment Therapy (ACT)

Intervention Type BEHAVIORAL

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.

Moderate to high Intensity Group Exercise

Intervention Type BEHAVIORAL

Group exercise led by supervised clinician with Cardiovascular focus to increase HR into zones to see adaptations to improve cardiovascular fitness.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pain Coping Skills Group Movement

Eligibility Criteria

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Inclusion Criteria

1. Age 18+
2. Non-cancer chronic pain (pain that occurs on at least half of the days of 6 months or more)
3. English fluency
4. Ability to attend \>70% treatment sessions to ensure active treatment is delivered

Exclusion Criteria

1. Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
2. Participants with acute cauda equina syndrome
3. Inability to complete a 6 minute walk test without LOB

3\) Chronic pain as explained by inflammatory disease

For the movement-based portions of group:

Exclusion: For our CBT + Movement (low intensity/ restorative) movement group: Patient must be able to sit upright for 20 minutes without loss of balance or upper extremity (UE) assistance. Inability to sit without use of UE support would be excluded. This ensures safety that the participant can completed the adapted movement program without risk of falls. HR will not be elevated \> 50% HRmax in these restorative movement classes.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No