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

Online "Pain, Stress & Emotions" Class in Chronic Pain: Single-arm Efficacy Test

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Pain, Stress and Emotions

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain, Stress, & Emotions Class; No active or placebo comparator will be used. This is a single-arm study design.	Behavioral: Pain, Stress and Emotions; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity NRS	Self-reported pain intensity rating	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a	self-reported pain interference levels	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Depression 6a	self-reported depression	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anxiety 6a	self-reported anxiety	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Physical Function 8b	self-reported physical functioning	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a	self-reported sleep disturbance	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: social isolation 6a	self-reported social isolation	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: fatigue 6a	self-reported fatigue	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: anger 5a	self-reported anger	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Ambivalence over Emotional Expression (AEQ)	self-reported ambivalence levels about emotional expression	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Emotion-Approach Coping	8-item emotion approach coping scale	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Bothersomeness	single-item assessing self-reported levels of pain bothersomeness	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Attributions Questionnaires	Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale	Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Collaborators and Investigators

• Sponsor: Stanford University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): March 20, 2022

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: StanfordClass

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No