Clinical trial NCT05014126: Online "Pain, Stress & Emotions" Class in Chronic Pain
Official title: Online "Pain, Stress & Emotions" Class in Chronic Pain: Single-arm Efficacy Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled, prospective, single arm, pre-post intervention study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity NRS
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: Depression 6a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: Anxiety 6a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: Physical Function 8b
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: social isolation 6a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: fatigue 6a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Patient-Reported Outcomes Measurement Information System: anger 5a
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Ambivalence over Emotional Expression (AEQ)
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Emotion-Approach Coping
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Pain Bothersomeness
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Other outcomes:
measure: Pain Attributions Questionnaires
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
measure: Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale
timeFrame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References:
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.
citation: 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.
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.
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):10.1111/nmo.13143. doi: 10.1111/nmo.13143. Epub 2017 Jun 22.