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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NR019196-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The purpose of this research is is to determine if the combination of non-opioid medication (duloxetine) and web-based pain-coping skills training (PCST) is beneficial for individuals with chronic musculoskeletal pain (CMP).
With this study, the study team hopes to address two important unanswered questions: (1) Does combination treatment consisting of duloxetine and web-based Cognitive Behavioral Therapy (CBT) optimize treatment outcomes? (2) Would adherence-focused guidance delivered by nurse clinician using motivational interviewing (MI) techniques enhance treatment effectiveness? This study is significant because the study team aims to optimize pain-related treatment outcomes at the primary care level where most patients with pain are managed. Importantly, the use of nurse clinician providing adherence-focused guidance (as opposed to content-focused guidance) on the continued practice (or use) of pain coping skills increases the likelihood that the study's intervention is scalable in the future. Effective, accessible and scalable psychoeducational treatments are needed to manage CMP in real world clinic settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| behavioral intervention, nurse support plus medication | Experimental | Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support. |
|
| behavioral intervention plus medication | Experimental | Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT). |
|
| medication only | Active Comparator | Subjects randomized to this arm will receive duloxetine only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine | Drug | All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) Total Pain Severity | BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity. | Baseline |
| Brief Pain Inventory (BPI) Total Pain Severity | BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity. | week 13 of treatment phase |
| Brief Pain Inventory (BPI) | BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity. | week 25 of treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | Adult Self-Reported Measures on physical function. The values of the response to each physical function question will be summed in order to determine the raw score. This must then be converted to the T-score. T-scores are standardized with a mean of 50 and a standard deviation of 10. I.e. a T-score of 40 would be one standard deviation lower than the mean. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function a T-score of 60 is one standard deviation better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis C Ang, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health Department of Rheumatology | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38762720 | Derived | Ang DC, Davuluri S, Kaplan S, Keefe F, Rini C, Miles C, Chen H. Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial. Trials. 2024 May 18;25(1):330. doi: 10.1186/s13063-024-08158-x. | |
| 38699346 | Derived | Ang DC, Davuluri S, Kaplan S, Keefe F, Rini C, Miles C, Chen H. Duloxetine and Cognitive Behavioral Therapy with Phone-based Support for the Treatment of Chronic Musculoskeletal Pain: Study Protocol of the PRECICE Randomized Control Trial. Res Sq [Preprint]. 2024 Apr 15:rs.3.rs-3924330. doi: 10.21203/rs.3.rs-3924330/v1. |
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Protecting the rights and privacy of our study participants is our first priority. After Internal Review Board approval for data sharing is obtained, a dataset that is de-identified and in accordance with HIPAA and other state and federal right to privacy laws will be developed by the investigators. Data obtained during the study will be made available beginning after publication of the main findings of the study. Notification of availability of de-identified data will be made in the acknowledgement section of all subsequent publications resulting from the study. Data will be provided in standard SAS format. Investigators interested in obtaining de-identified study data will be instructed to send a blank compact disc to the primary investigator for copying.
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Immediately following publication. No end date.
For individual participant data, meta-analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Intervention, Nurse Support Plus Medication | Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average. |
| FG001 | Behavioral Intervention Plus Medication | Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT). duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. |
| FG002 | Medication Only | Subjects randomized to this arm will receive duloxetine only. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Intervention, Nurse Support Plus Medication | Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brief Pain Inventory (BPI) Total Pain Severity | BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
25 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Intervention, Nurse Support Plus Medication | Subjects randomized to this arm will receive duloxetine, web-based Cognitive Behavioral Therapy (CBT) and nurse support. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. Nurse-delivered Motivational Interviewing: Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis C. Ang | Wake Forest School of Medicine | 3367058701 | dang@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2022 | Apr 10, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 5, 2024 | Jan 30, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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The project manager, who is blinded of treatment group assignment, has the primary responsibility of collecting outcome data throughout the study.
|
| Web-based Cognitive Behavioral Therapy (CBT) | Behavioral | The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. |
|
| Nurse-delivered Motivational Interviewing | Other | Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average. |
|
| week 25 of treatment phase |
| Patient Health Questionnaire 8-Item Depression Scale (PHQ-8) | Score is the sum of the 8 items. Score ranges from 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. | week 25 of treatment phase |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | Score ranges from 0-24. Scores of 5, 10, and 15 are the respective cut-offs for mild, moderate, and severe anxiety. Further evaluation is recommended when a score of 10 or greater is recorded. | week 25 of treatment phase |
| missed appointment |
|
| BG001 | Behavioral Intervention Plus Medication | Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT). duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. |
| BG002 | Medication Only | Subjects randomized to this arm will receive duloxetine only. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Brief Pain Inventory (BPI) total pain severity | Brief Pain Inventory (BPI) score ranges from 0 to 10 with a higher score denoting a higher pain severity. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Behavioral Intervention Plus Medication | Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT). duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. |
| OG002 | Medication Only | Subjects randomized to this arm will receive duloxetine only. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. |
|
|
| Primary | Brief Pain Inventory (BPI) Total Pain Severity | BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity. | Posted | Mean | Standard Error | score on a scale | week 13 of treatment phase |
|
|
|
| Primary | Brief Pain Inventory (BPI) | BPI score ranges from 0 to 10 with a higher score denoting a higher pain severity. | 18 participants in the intervention/nurse/med group did not complete week 25 visit, 14 participants from the intervention/med group did not complete week 25 visit, 9 participants from the med only group did not complete week 25 visit | Posted | Mean | Standard Error | score on a scale | week 25 of treatment phase |
|
|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function | Adult Self-Reported Measures on physical function. The values of the response to each physical function question will be summed in order to determine the raw score. This must then be converted to the T-score. T-scores are standardized with a mean of 50 and a standard deviation of 10. I.e. a T-score of 40 would be one standard deviation lower than the mean. A higher PROMIS T-score represents more of the concept being measured. For positively-worded concepts like Physical Function a T-score of 60 is one standard deviation better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average. | 18 participants in the intervention/nurse/med group did not complete week 25 visit, 14 participants from the intervention/med group did not complete week 25 visit, 9 participants from the med only group did not complete week 25 visit | Posted | Mean | Standard Error | T score | week 25 of treatment phase |
|
|
|
| Secondary | Patient Health Questionnaire 8-Item Depression Scale (PHQ-8) | Score is the sum of the 8 items. Score ranges from 0-24. A score of 10 or greater is considered major depression, 20 or more is severe major depression. | Posted | Mean | Standard Error | score on a scale | week 25 of treatment phase |
|
|
|
| Secondary | Generalized Anxiety Disorder 7-item Scale (GAD-7) | Score ranges from 0-24. Scores of 5, 10, and 15 are the respective cut-offs for mild, moderate, and severe anxiety. Further evaluation is recommended when a score of 10 or greater is recorded. | 18 participants in the intervention/nurse/med group did not complete week 25 visit, 14 participants from the intervention/med group did not complete week 25 visit, 9 participants from the med only group did not complete week 25 visit | Posted | Mean | Standard Error | score on a scale | week 25 of treatment phase |
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 0 |
| 93 |
| EG001 | Behavioral Intervention Plus Medication | Subjects randomized to this arm will receive duloxetine and web-based Cognitive Behavioral Therapy (CBT). duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. Web-based Cognitive Behavioral Therapy (CBT): The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT. | 0 | 93 | 0 | 93 | 0 | 93 |
| EG002 | Medication Only | Subjects randomized to this arm will receive duloxetine only. duloxetine: All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks. | 0 | 94 | 0 | 94 | 0 | 94 |
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| D006571 |
| Heterocyclic Compounds |