Online "Pain, Stress & Emotions" Class in Chronic Pain

NCT05014126 | Completed Early Phase 1

• 1 other identifier: StanfordClass
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, \& Emotions". Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks after class attendance.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity NRS

  Self-reported pain intensity rating

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Secondary Outcomes (11)

• Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

• Patient-Reported Outcomes Measurement Information System: Depression 6a

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

• Patient-Reported Outcomes Measurement Information System: Anxiety 6a

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

• Patient-Reported Outcomes Measurement Information System: Physical Function 8b

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

• Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Other Outcomes (2)

• Pain Attributions Questionnaires

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

• Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale

  Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Study Arms (1)

Pain, Stress, & Emotions Class

EXPERIMENTAL

No active or placebo comparator will be used. This is a single-arm study design.

Behavioral: Pain, Stress and Emotions

Interventions

Pain, Stress and Emotions BEHAVIORAL

2-hour, zoom-delivered, group intervention focused on teaching patients how pain is processed in their brain and learning about the role of psychosocial factors in their pain conditions.

Pain, Stress, & Emotions Class

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic pain condition (pain \> 3 months)
• Access to the internet
• English fluency

You may not qualify if:

• Ongoing legal action or disability claim
• Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (5)

• Holmes HJ, Thakur ER, Carty JN, Ziadni MS, Doherty HK, Lockhart NA, Schubiner H, Lumley MA. Ambivalence over emotional expression and perceived social constraints as moderators of relaxation training and emotional awareness and expression training for irritable bowel syndrome. Gen Hosp Psychiatry. 2018 Jul-Aug;53:38-43. doi: 10.1016/j.genhosppsych.2018.05.002. Epub 2018 May 3.

  PMID: 29751205 BACKGROUND

• Carty JN, Ziadni MS, Holmes HJ, Tomakowsky J, Peters K, Schubiner H, Lumley MA. The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial. Pain Med. 2019 Jul 1;20(7):1321-1329. doi: 10.1093/pm/pny182.

  PMID: 30252113 BACKGROUND

• Ziadni MS, Carty JN, Doherty HK, Porcerelli JH, Rapport LJ, Schubiner H, Lumley MA. A life-stress, emotional awareness, and expression interview for primary care patients with medically unexplained symptoms: A randomized controlled trial. Health Psychol. 2018 Mar;37(3):282-290. doi: 10.1037/hea0000566. Epub 2017 Nov 20.

  PMID: 29154608 BACKGROUND

• Thakur ER, Holmes HJ, Lockhart NA, Carty JN, Ziadni MS, Doherty HK, Lackner JM, Schubiner H, Lumley MA. Emotional awareness and expression training improves irritable bowel syndrome: A randomized controlled trial. Neurogastroenterol Motil. 2017 Dec;29(12):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.

  PMID: 28643436 BACKGROUND

• Ziadni MS, Sturgeon JA, Lumley MA. "Pain, Stress, and Emotions": Uncontrolled trial of a single-session, telehealth, emotional awareness and expression therapy class for patients with chronic pain. Front Pain Res (Lausanne). 2022 Nov 18;3:1028561. doi: 10.3389/fpain.2022.1028561. eCollection 2022.

  PMID: 36466215 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Uncontrolled, prospective, single arm, pre-post intervention study

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 20, 2021
• Study Start: August 20, 2021
• Primary Completion: January 15, 2022
• Study Completion: March 20, 2022
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)