Development and Validation of a Daily Pain Catastrophizing Scale

June 6, 2019 updated by: Beth Darnall, Stanford University

Development and Validation of a Daily Pain Catastrophizing Scale Based Measure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

713

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with chronic pain.

Description

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

Exclusion Criteria:

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Questionnaires
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.
Behavioral: Questionnaires
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.
Behavioral: Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factor Analysis & PROMIS Correlation for Samples 2 & 3
Time Frame: 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.
14 days

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Beth D Darnall, PhD, 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

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 16, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

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)?

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.

Clinical Trials on Chronic Pain

Clinical Trials on Questionnaires

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe