Chronic Pain
Conditions
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.
Interventions
BEHAVIORALQuestionnaires
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 131 |
| 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. | 177 |
| Validation Sample 3 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. | 211 |
| Total | 519 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 55 | 32 | 107 |
Baseline characteristics
| Characteristic | Validation Sample 1 | Validation Sample 2 | Validation Sample 3 | Total |
|---|---|---|---|---|
| Age, Customized Median Categorical Age | 55 years | 55 years | 45 years | 52 years |
| Sex: Female, Male Female | 109 Participants | 122 Participants | 186 Participants | 417 Participants |
| Sex: Female, Male Male | 22 Participants | 55 Participants | 25 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 186 | 0 / 209 | 0 / 318 |
| serious Total, serious adverse events | 0 / 186 | 0 / 209 | 0 / 318 |
Outcome results
Primary
Factor Analysis & PROMIS Correlation for Samples 2 & 3
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.
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Validation Sample 1 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Anxiety (Daily Construct for Sample 3) | NA Pearson Coefficients |
| Validation Sample 1 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Depression (Daily Construct for Sample 3) | NA Pearson Coefficients |
| Validation Sample 1 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | PCS 3-item | NA Pearson Coefficients |
| Validation Sample 1 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Pain Intensity (Daily Construct for Sample 3) | NA Pearson Coefficients |
| Validation Sample 1 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Anger (Daily Construct for Sample 3) | NA Pearson Coefficients |
| Validation Sample 2 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Depression (Daily Construct for Sample 3) | .441 Pearson Coefficients |
| Validation Sample 2 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | PCS 3-item | .990 Pearson Coefficients |
| Validation Sample 2 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Pain Intensity (Daily Construct for Sample 3) | .581 Pearson Coefficients |
| Validation Sample 2 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Anxiety (Daily Construct for Sample 3) | .378 Pearson Coefficients |
| Validation Sample 2 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Anger (Daily Construct for Sample 3) | .548 Pearson Coefficients |
| Validation Sample 3 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Anger (Daily Construct for Sample 3) | .488 Pearson Coefficients |
| Validation Sample 3 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Anxiety (Daily Construct for Sample 3) | .518 Pearson Coefficients |
| Validation Sample 3 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | PCS 3-item | NA Pearson Coefficients |
| Validation Sample 3 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Depression (Daily Construct for Sample 3) | .573 Pearson Coefficients |
| Validation Sample 3 | Factor Analysis & PROMIS Correlation for Samples 2 & 3 | Pain Intensity (Daily Construct for Sample 3) | .528 Pearson Coefficients |