- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02778555
Development and Validation of a Daily Pain Catastrophizing Scale
Development and Validation of a Daily Pain Catastrophizing Scale Based Measure
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 or above
- Chronic pain of any etiology
- Online access
- Ability to participate in daily measurements over 14 days
Exclusion Criteria:
1. Lack of ability to answer questionnaires and daily catastrophizing captures, at the discretion of study staff.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Sample 1
In Sample 1 (N=186), our 14-item Daily PCS was administered daily for 14 days to replicate the 3-factor structure at the daily level, and to select the ideal 5 items for a brief Daily PCS.
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Sample 2
In Sample 2 (N=209), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14.
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Sample 3
In Sample 3 (N=318), the 5-item Daily PCS was administered daily for 14 days with short forms for PROMIS Pain Intensity, Depression, Anger, and Anxiety included on days 1, 7, and 14.
In addition, assessments of pain, mood, activity, sleep, energy level, and positive affect were administered daily for the 14-day period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Factor Analysis & PROMIS Correlation for Samples 2 & 3
Time Frame: 14 days
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The validation process involves identifying, of the original 14 PCS items, which items show the largest factor loadings to the underlying factor structure that fits the data best, using model fit indices that will determine appropriate fit of the statistical model to the data, as well as convergent validity with other relevant measures (pain intensity, depression, anxiety, anger), which is tested through the use of Pearson correlations. Metrics used to test the hypothesis: Intraclass correlations were used to establish variability. RMSEA, CFI, TLI, and WRMR as our goodness of fit indices for arriving at 3- and 5-item measures, and to compare the measures. Reliability was tested using α. Correlations between daily pain, mood, activity, sleep, and energy were tested using pearson coefficients. Intent was to measure correlations between the brief PCS and the PROMIS for validation sample 2, and correlations between the brief PCS and the PROMIS for validation sample 3. |
14 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beth D Darnall, PhD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT008561-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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