Development and Validation of a Daily Pain Catastrophizing Scale

Completed

• Conditions: Chronic Pain
• Interventions: Behavioral: Questionnaires

• Registration Number: NCT02778555
• Lead Sponsor: Stanford University

Brief Summary

This study sought to develop and validate a brief, daily version of the Pain Catastrophizing Scale.

Detailed Description

The Pain Catastrophizing Scale (PCS; 13 items; factors: rumination, helplessness, magnification) (Sullivan 1995) measures trait catastrophizing in the context of actual or anticipated pain. Currently, there is no validated tool for measuring pain catastrophizing at the daily level. Lack of a validated daily measure stands as a barrier for studies that aim to characterize mechanisms of pain treatment and how PC adaptation / change occurs.

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-20
• Results First Submitted: 2016-11-22
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-06
• Last Update Submitted: 2019-06-06
• Results First Posted: 2019-06-27
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 713

Inclusion Criteria

1. Age 18 or above
2. Chronic pain of any etiology
3. Online access
4. Ability to participate in daily measurements over 14 days

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Exclusion Criteria

1. Lack of ability to answer questionnaires and daily catastrophizing captures, at the discretion of study staff.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sample 1	Questionnaires	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.
Sample 3	Questionnaires	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.
Sample 2	Questionnaires	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.

Primary Outcome Measures

Name	Time	Method
Factor Analysis & PROMIS Correlation for Samples 2 & 3	14 days	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.