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

NCT05812703 | Not Yet Recruiting

• 1 other identifier: 66952
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Sedentary Time

Keywords

movement; behavioral treatments; biometrics; chronic pain

Outcome Measures

Primary Outcomes (1)

• Change in sedentary behavior time

  Sedentary behavior is defined as any waking behavior such as sitting or leaning with an energy expenditure of 1.5 metabolic equivalent task (MET) or less

  Pre intervention (baseline), and post intervention (at 10 weeks)

Secondary Outcomes (12)

• HF-Heart rate variability

  Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)

• Sleep Duration

  Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)

• Daily Step Count

  Pre intervention (baseline), end of treatment session (week 6), and post intervention (at 10 weeks)

• Pain Catastrophizing

  Pre intervention (baseline), and post intervention (at 10 weeks) and 6 months follow up (post group)

• PROMIS Depression Score

  Pre intervention (baseline), and post intervention (at 10 weeks),and 6 months follow up (post group)

Study Arms (3)

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).

Behavioral: Cognitive Behavioral Therapy

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.

Behavioral: Acceptance and Commitment Therapy (ACT)

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.

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

Interventions

Cognitive Behavioral Therapy 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.

Also known as: Pain Coping Skills, Group Movement

Behavioral Group Treatment (Cognitive Behavioral Therapy CBT + Movement)

Acceptance and Commitment Therapy (ACT) 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; Behavioral Group Treatment (ACT) only

Moderate to high Intensity Group Exercise BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We will include self-reported gender preferences
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic pain

You may qualify if:

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

You may not qualify if:

• Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
• Participants with acute cauda equina syndrome
• Inability to complete a 6 minute walk test without LOB
• \) Chronic pain as explained by inflammatory disease
• For the movement-based portions of group:

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Pain Management Clinic

Redwood City, California, 94061, United States

Location

Related Publications (6)

• You DS, Ziadni MS, Cooley CE, Talavera DC, Mackey SC, Poupore-King H. Effectiveness of a multidisciplinary rehabilitation program in real-world patients with chronic back pain: A pilot cohort data analysis. J Back Musculoskelet Rehabil. 2021;34(6):965-973. doi: 10.3233/BMR-200305.

  PMID: 34151829 BACKGROUND

• Neumann A, Hampel P. Long-term effects of rehabilitation and prevention of further chronification of pain among patients with non-specific low back pain. J Back Musculoskelet Rehabil. 2022;35(6):1257-1268. doi: 10.3233/BMR-210221.

  PMID: 35754259 BACKGROUND

• Pears S, Sutton S. Effectiveness of Acceptance and Commitment Therapy (ACT) interventions for promoting physical activity: a systematic review and meta-analysis. Health Psychol Rev. 2021 Mar;15(1):159-184. doi: 10.1080/17437199.2020.1727759. Epub 2020 Feb 17.

  PMID: 32036768 BACKGROUND

• Mercer K, Li M, Giangregorio L, Burns C, Grindrod K. Behavior Change Techniques Present in Wearable Activity Trackers: A Critical Analysis. JMIR Mhealth Uhealth. 2016 Apr 27;4(2):e40. doi: 10.2196/mhealth.4461.

  PMID: 27122452 BACKGROUND

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.

  PMID: 29034226 BACKGROUND

• Karayannis NV, Sturgeon JA, Kemani MK, Mackey SC, Greco CM, Wicksell RK, McCracken LM. Pain acceptance and psychological inflexibility predict pain interference outcomes for persons with chronic pain receiving pain psychology. Scand J Pain. 2023 Feb 7;23(3):464-475. doi: 10.1515/sjpain-2022-0107. Print 2023 Jul 26.

  PMID: 36745187 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

HR variability, Activity (steps), Sedentary time, Sleep Stages (REM, light, deep)

MeSH Terms

Conditions

Chronic Pain; Sedentary Behavior

Interventions

Cognitive Behavioral Therapy; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Heather King, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 14, 2023
• Study Start: September 27, 2024
• Primary Completion: October 25, 2025
• Study Completion: April 25, 2026
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)