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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014126
• Other study ID #: StanfordClass
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 20, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: May 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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). doi: 10.1111/nmo.13143. Epub 2017 Jun 22. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	Pain Intensity NRS	Self-reported pain intensity rating	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Emotion-Approach Coping	8-item emotion approach coping scale	Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Secondary	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)