Trial Outcomes & Findings for Pain Catastrophizing and Prescription Opioid Craving (NCT NCT04097743)

NCT ID: NCT04097743

Last Updated: 2026-01-12

Results Overview

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 93 participants
• Primary outcome timeframe: At day 7 (after intervention)
• Results posted on: 2026-01-12

Participant Flow

Participant milestones

Measure	Coping Statement Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control No instruction about pain coping statement.
Overall Study STARTED	44	49
Overall Study COMPLETED	43	49
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Coping Statement Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control No instruction about pain coping statement.
Overall Study Non-compliance of the study instruction.	1	0

Baseline Characteristics

Pain Catastrophizing and Prescription Opioid Craving

Baseline characteristics by cohort

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.	Total n=93 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 13.4 • n=210 Participants	61.6 years STANDARD_DEVIATION 9.83 • n=19 Participants	61.0 years STANDARD_DEVIATION 11.6 • n=8 Participants
Sex: Female, Male Female	25 Participants n=210 Participants	29 Participants n=19 Participants	54 Participants n=8 Participants
Sex: Female, Male Male	19 Participants n=210 Participants	20 Participants n=19 Participants	39 Participants n=8 Participants
Race/Ethnicity, Customized White/Caucasian	40 Participants n=210 Participants	37 Participants n=19 Participants	77 Participants n=8 Participants
Race/Ethnicity, Customized White/Hispanic/Latino	1 Participants n=210 Participants	4 Participants n=19 Participants	5 Participants n=8 Participants
Race/Ethnicity, Customized African American/Black	0 Participants n=210 Participants	4 Participants n=19 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized Asian	2 Participants n=210 Participants	2 Participants n=19 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Pacific Islander/Native Hawaiian	0 Participants n=210 Participants	0 Participants n=19 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Prefer not to say	0 Participants n=210 Participants	2 Participants n=19 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Other	1 Participants n=210 Participants	0 Participants n=19 Participants	1 Participants n=8 Participants
Opioid Craving Craving	27 Participants n=210 Participants	27 Participants n=19 Participants	54 Participants n=8 Participants
Opioid Craving Non-craving	16 Participants n=210 Participants	22 Participants n=19 Participants	38 Participants n=8 Participants

PRIMARY outcome

Timeframe: At day 7 (after intervention)

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Craving	12.68 score on a scale Standard Deviation 20.06	18.49 score on a scale Standard Deviation 27.76

PRIMARY outcome

Timeframe: At day 14 (7 days after intervention)

Craving was assessed using a 0-100 Visual Analogue Scale (VAS), with higher scores indicating greater craving in the past 24 hours.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Craving	12.77 score on a scale Standard Deviation 12.84	21.40 score on a scale Standard Deviation 22.92

SECONDARY outcome

Timeframe: At day 7 (after intervention)

Salivary cortisol level was the mean of samples collected at wake-up, 30 minutes after waking, and at 9:00 PM. Higher scores indicate higher cortisol levels.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Cortisol	0.41 ug/dL Standard Deviation 0.62	0.84 ug/dL Standard Deviation 3.19

SECONDARY outcome

Timeframe: At day 14 (7 days after intervention)

Salivary cortisol level was the mean of samples collected at wake-up, 30 minutes after waking, and at 9:00 PM. Possible scores range 0.012-3.000 ug/dL. Higher scores indicate higher cortisol levels.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Cortisol	0.53 ug/dL Standard Deviation 1.62	0.35 ug/dL Standard Deviation 0.41

SECONDARY outcome

Timeframe: At day 7 (after intervention)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80 and Higher scores indicate greater anxiety symptoms.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Anxiety Symptoms	52.27 T-score Standard Deviation 8.88	50.14 T-score Standard Deviation 8.31

SECONDARY outcome

Timeframe: At day 14 (7 days after intervention)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater anxiety symptoms.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Anxiety Symptoms	52.91 T-score Standard Deviation 49.79	11.04 T-score Standard Deviation 8.84

SECONDARY outcome

Timeframe: At day 7 (after intervention)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater depression symptoms.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Depression Symptoms	51.08 T-score Standard Deviation 9.35	41.31 T-score Standard Deviation 8.31

SECONDARY outcome

Timeframe: At day 14 (7 days after intervention)

The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8-item short form was administered. 50 indicates the population mean with a standard deviation of 10. Possible T-Scores range from 20 - 80. Higher scores indicate greater depression symptoms.

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Depression Symptoms	51.02 score on a scale Standard Deviation 9.36	48.53 score on a scale Standard Deviation 8.89

SECONDARY outcome

Timeframe: At day 14 (7 days after intervention)

The Current Opioid Misuse Measure (COMM), a 17-item questionnaire, was administered. Scores represent the total summed score and range from 0 to 68, with higher scores indicating greater opioid misuse

Outcome measures

Measure	Coping Statement n=44 Participants Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 Participants No instruction about pain coping statement.
Prescription Opioid Misuse	8.30 total score on a scale Standard Deviation 7.90	7.47 total score on a scale Standard Deviation 6.67

Adverse Events

Coping Statement

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Coping Statement n=44 participants at risk Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 participants at risk No instruction about pain coping statement.
Psychiatric disorders Suicidal thought without intent	2.3% 1/44 • Number of events 1 • 14 days	0.00% 0/49 • 14 days

Other adverse events

Measure	Coping Statement n=44 participants at risk Daily practice of pain coping statements for 7 days Coping Statement: Daily practice of coping statement	Control n=49 participants at risk No instruction about pain coping statement.
Respiratory, thoracic and mediastinal disorders Respiratory Infection	4.5% 2/44 • Number of events 2 • 14 days	8.2% 4/49 • Number of events 4 • 14 days
Renal and urinary disorders Bladder Infection	0.00% 0/44 • 14 days	2.0% 1/49 • Number of events 1 • 14 days
Musculoskeletal and connective tissue disorders Pain Flare-up	6.8% 3/44 • Number of events 3 • 14 days	10.2% 5/49 • Number of events 5 • 14 days
Musculoskeletal and connective tissue disorders Bodily injury	2.3% 1/44 • Number of events 1 • 14 days	4.1% 2/49 • Number of events 2 • 14 days
Musculoskeletal and connective tissue disorders Surgery	0.00% 0/44 • 14 days	2.0% 1/49 • Number of events 1 • 14 days
Social circumstances Financial hardship	2.3% 1/44 • Number of events 1 • 14 days	0.00% 0/49 • 14 days

Additional Information

Dokyoung Sophia You, PhD

University of Oklahoma

Phone: 9186603923

Email: dokyoung-you@ou.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place