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CompletedNCT05014126Updated Nov 5, 2024

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

An Early Phase 1 interventional study of Pain, Stress and Emotions in Chronic Pain, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by Stanford University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.

This study's enrollment of 74 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralPain, 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.

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What researchers measure

Primary outcomes

  1. Pain Intensity NRS

    Self-reported pain intensity rating

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

Secondary outcomes

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

    self-reported pain interference levels

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

  2. Patient-Reported Outcomes Measurement Information System: Depression 6a

    self-reported depression

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

  3. Patient-Reported Outcomes Measurement Information System: Anxiety 6a

    self-reported anxiety

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

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

    self-reported physical functioning

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

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

    self-reported sleep disturbance

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

  6. Patient-Reported Outcomes Measurement Information System: social isolation 6a

    self-reported social isolation

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

  7. Patient-Reported Outcomes Measurement Information System: fatigue 6a

    self-reported fatigue

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

  8. Patient-Reported Outcomes Measurement Information System: anger 5a

    self-reported anger

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

  9. Ambivalence over Emotional Expression (AEQ)

    self-reported ambivalence levels about emotional expression

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

  10. Emotion-Approach Coping

    8-item emotion approach coping scale

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

  11. Pain Bothersomeness

    single-item assessing self-reported levels of pain bothersomeness

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

Other outcomes

  1. 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 \[psychological attribution\])

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

  2. 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)

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

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Study locations

1 site
  • Stanford University
    Palo Alto, California 94304, United States
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References and documents

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. PubMed 29751205 ↗
  • 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. PubMed 30252113 ↗
  • 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. PubMed 29154608 ↗
  • 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. PubMed 28643436 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05014126
Lead sponsor
Stanford University
Responsible party
Maisa Ziadni (Principal Investigator, Stanford University) — Principal investigator
First posted
Aug 20, 2021
Start date
Aug 20, 2021
Primary completion
Jan 15, 2022
Completion
Mar 20, 2022
Last update
Nov 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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