Trial Outcomes & Findings for Development and Validation of a Daily Pain Catastrophizing Scale (NCT NCT02778555)
NCT ID: NCT02778555
Last Updated: 2019-06-27
Results Overview
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.
COMPLETED
713 participants
14 days
2019-06-27
Participant Flow
Participant milestones
| Measure |
Validation 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.
|
Validation 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.
|
Validation 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
186
|
209
|
318
|
|
Overall Study
COMPLETED
|
131
|
177
|
211
|
|
Overall Study
NOT COMPLETED
|
55
|
32
|
107
|
Reasons for withdrawal
| Measure |
Validation 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.
|
Validation 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.
|
Validation 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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
55
|
32
|
107
|
Baseline Characteristics
Development and Validation of a Daily Pain Catastrophizing Scale
Baseline characteristics by cohort
| Measure |
Validation Sample 1
n=131 Participants
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.
|
Validation Sample 2
n=177 Participants
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.
|
Validation Sample 3
n=211 Participants
In Sample 3 (N=305), 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.
|
Total
n=519 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Median Categorical Age
|
55 years
n=5 Participants
|
55 years
n=7 Participants
|
45 years
n=5 Participants
|
52 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
109 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
417 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 14 daysThe 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.
Outcome measures
| Measure |
Validation Sample 1
n=131 Participants
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.
|
Validation Sample 2
n=177 Participants
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.
|
Validation Sample 3
n=211 Participants
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.
|
|---|---|---|---|
|
Factor Analysis & PROMIS Correlation for Samples 2 & 3
PCS 3-item
|
NA Pearson Coefficients
First sample, no group to correlate as PCS
|
.990 Pearson Coefficients
|
NA Pearson Coefficients
Not correlated with PCS 3-item as PCS 5-item was used. Primary aim for Study 3 was to correlate daily constructs (pain intensity, sleep, energy, activity, depression, anxiety, anger, positive affect)
|
|
Factor Analysis & PROMIS Correlation for Samples 2 & 3
Pain Intensity (Daily Construct for Sample 3)
|
NA Pearson Coefficients
First sample, no group to correlate.
|
.581 Pearson Coefficients
|
.528 Pearson Coefficients
|
|
Factor Analysis & PROMIS Correlation for Samples 2 & 3
Depression (Daily Construct for Sample 3)
|
NA Pearson Coefficients
First sample, no group to correlate.
|
.441 Pearson Coefficients
|
.573 Pearson Coefficients
|
|
Factor Analysis & PROMIS Correlation for Samples 2 & 3
Anxiety (Daily Construct for Sample 3)
|
NA Pearson Coefficients
First sample, no group to correlate.
|
.378 Pearson Coefficients
|
.518 Pearson Coefficients
|
|
Factor Analysis & PROMIS Correlation for Samples 2 & 3
Anger (Daily Construct for Sample 3)
|
NA Pearson Coefficients
First sample, no group to correlate.
|
.548 Pearson Coefficients
|
.488 Pearson Coefficients
|
Adverse Events
Validation Sample 1
Validation Sample 2
Validation Sample 3
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Beth Darnall, Clinical Associate Professor, Division of Pain Medicine
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place