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

Stanford University

Status: Not yet enrolling

Conditions: Chronic Pain; Sedentary Time

Treatments: Behavioral: Moderate to high Intensity Group Exercise; Behavioral: Acceptance and Commitment Therapy (ACT); Behavioral: Cognitive Behavioral Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05812703

66952

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria for the Back in ACTion (higher intensity) movement group is inability to complete a 6-minute walk test safely or without loss of balance, as this poses a fall risk that requires individual assistance throughout the class, or medical exclusion from cardiovascular exercise over 50% HRmax, as HR will be elevated to 50-70% HR max in these classes.

Trial design

50 participants in 3 patient groups

Behavioral Group Treatment (Cognitive Behavioral Therapy CBT + Movement)

Description:

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).

Treatment:

Behavioral: Cognitive Behavioral Therapy

Behavioral Group Treatment (ACT) only

Description:

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.

Treatment:

Behavioral: Acceptance and Commitment Therapy (ACT)

Behavioral Group Treatment (ACT + Movement)- Back in ACTion

Description:

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.

Treatment:

Behavioral: Acceptance and Commitment Therapy (ACT)

Behavioral: Moderate to high Intensity Group Exercise