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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05014126
Other study ID # StanfordClass
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
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