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Completed

NCT Number: NCT05014126

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

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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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain, Stress and Emotions

Behavioral

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 outcomes

  1. Pain Intensity NRS

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

    Self-reported pain intensity rating

Secondary outcomes

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

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

    self-reported pain interference levels

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

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

    self-reported depression

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

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

    self-reported anxiety

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

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

    self-reported physical functioning

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

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

    self-reported sleep disturbance

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

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

    self-reported social isolation

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

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

    self-reported fatigue

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

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

    self-reported anger

  9. Ambivalence over Emotional Expression (AEQ)

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

    self-reported ambivalence levels about emotional expression

  10. Emotion-Approach Coping

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

    8-item emotion approach coping scale

  11. Pain Bothersomeness

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

    single-item assessing self-reported levels of pain bothersomeness

Other outcomes

  1. Pain Attributions Questionnaires

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

    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])

  2. Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale

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

    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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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