Online "Pain, Stress & Emotions" Class in Chronic Pain
Primary Purpose
Chronic Pain
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pain, Stress and Emotions
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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.
Sites / Locations
- Stanford UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain, Stress, & Emotions Class
Arm Description
No active or placebo comparator will be used. This is a single-arm study design.
Outcomes
Primary Outcome Measures
Pain Intensity NRS
Self-reported pain intensity rating
Secondary Outcome Measures
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
self-reported pain interference levels
Patient-Reported Outcomes Measurement Information System: Depression 6a
self-reported depression
Patient-Reported Outcomes Measurement Information System: Anxiety 6a
self-reported anxiety
Patient-Reported Outcomes Measurement Information System: Physical Function 8b
self-reported physical functioning
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
self-reported sleep disturbance
Patient-Reported Outcomes Measurement Information System: social isolation 6a
self-reported social isolation
Patient-Reported Outcomes Measurement Information System: fatigue 6a
self-reported fatigue
Patient-Reported Outcomes Measurement Information System: anger 5a
self-reported anger
Ambivalence over Emotional Expression (AEQ)
self-reported ambivalence levels about emotional expression
Emotion-Approach Coping
8-item emotion approach coping scale
Pain Bothersomeness
single-item assessing self-reported levels of pain bothersomeness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05014126
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled, prospective, single arm, pre-post intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain, Stress, & Emotions Class
Arm Type
Experimental
Arm Description
No active or placebo comparator will be used. This is a single-arm study design.
Intervention Type
Behavioral
Intervention Name(s)
Pain, Stress and Emotions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Intensity NRS
Description
Self-reported pain intensity rating
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
Description
self-reported pain interference levels
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: Depression 6a
Description
self-reported depression
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: Anxiety 6a
Description
self-reported anxiety
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: Physical Function 8b
Description
self-reported physical functioning
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
Description
self-reported sleep disturbance
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: social isolation 6a
Description
self-reported social isolation
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: fatigue 6a
Description
self-reported fatigue
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Patient-Reported Outcomes Measurement Information System: anger 5a
Description
self-reported anger
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Ambivalence over Emotional Expression (AEQ)
Description
self-reported ambivalence levels about emotional expression
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Emotion-Approach Coping
Description
8-item emotion approach coping scale
Time Frame
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Title
Pain Bothersomeness
Description
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 Pre-specified Outcome Measures:
Title
Pain Attributions Questionnaires
Description
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)
Title
Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maisa Ziadni, PhD
Phone
650-736-5494
Email
mziadni@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29751205
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.
Results Reference
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PubMed Identifier
30252113
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.
Results Reference
background
PubMed Identifier
29154608
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.
Results Reference
background
PubMed Identifier
28643436
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.
Results Reference
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Online "Pain, Stress & Emotions" Class in Chronic Pain
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