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

November 4, 2024 updated by: Maisa Ziadni, Stanford University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Intensity NRS
Time Frame: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Self-reported pain intensity rating
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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])
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
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)
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • StanfordClass

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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