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Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management

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ClinicalTrials.gov Identifier: NCT03927846
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
To see if nurse guided web based cognitive behavioral therapy (CBT) will show pain improvement in patients with all types of pain complaints.

Condition or disease Intervention/treatment Phase
Chronic Musculoskeletal Pain Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy Not Applicable

Detailed Description:
The primary objective of this application is to test the feasibility of a care model where clinic nurses play a vital role in promoting the adoption of web-based CBT in the ambulatory medical setting. Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique. The investigators will use outcome measures including the number of completed web-based learning modules, amount of time spent by the nurses on study-related and non-study related phone calls, health care use, and clinical variables. Our proposed line of research is significant because it will potentially make CBT, a significantly underutilized treatment modality, potentially more affordable and accessible. If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist Health System can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. Wake Baptist may also develop its own web-based CBT for commercial use.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants (n=60) in the primary care and rheumatology clinics will be randomized to one of 2 arms: (1) 6 regular telephone contacts, vs. (2) 6 computer generated email reminders (control arm) over an 8-week period. To enhance participants' motivation to engage in the web-based CBT, nurses will use motivational interviewing technique.
Masking: Single (Outcomes Assessor)
Masking Description: Study coordinator will be blinded to randomization
Primary Purpose: Supportive Care
Official Title: Web-based Pain Self-Management: Nurse-Guided
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Active Comparator: Telephone Contact (Nurse)
6 regular telephone contacts by nurses who will use a motivational interviewing technique
Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.

Active Comparator: E-mail contact
6 computer generated email reminders (control arm) over an 8-week period.
Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.




Primary Outcome Measures :
  1. PROMIS (patient reported-outcomes measurement information system) pain intensity [ Time Frame: Up to Week 16 ]
    Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome

  2. PROMIS pain interference [ Time Frame: Up to Week 16 ]
    Questionnaire that measures interference of pain on subject's life. The possible score range is 6-30, six being the best outcome and 30 being the worst outcome.


Secondary Outcome Measures :
  1. Completed phone calls [ Time Frame: Up to Week 16 ]
    The number of completed phone calls by the nurse will be recorded.

  2. Completed learning modules per treatment arm [ Time Frame: Week 16 ]
    The number of completed learning modules per treatment arm will be recorded.


Other Outcome Measures:
  1. Proportion of subjects with Interest in pain self-management [ Time Frame: Up to Week 16 ]
    This refers to the acceptability a subject has to pain self management. This would be determined by the number of subjects who answer "yes" to the question "Have you ever wondered if there is something that you could do on your own to better manage your pain?" divided by the number of patients who answered "yes" to the question "Over the last 6 months, do you have daily or almost daily pain that interfered with your general activity or enjoyment of life?"

  2. Proportion of patients who viewed educational video [ Time Frame: Up to Week 16 ]
    This refers to the acceptability a subject has to watching the educational video on web-based CBTi. This would be determined by the number of patients who watched the video from EMMI divided by the number of patients who received the video from EMMI.

  3. Proportion of subjects who called the research coordinator to participate in the study. [ Time Frame: Up to Week 16 ]
    This refers to the acceptability a subject has to participating in the study. This would be determined by the number of patients who made a phone call to the research team after watching the video divided by the number of patients who watched the video.

  4. Ratings of perceived disruption [ Time Frame: Up to Week 16 ]
    This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures

  5. Uptake rates [ Time Frame: Up to Week 16 ]
    This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. For the uptake rate, the number of times participants log in to web-based CBT will be recorded.

  6. Self-report frequency of practicing pain coping skills [ Time Frame: Up to Week 16 ]
    This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Self-report frequency of practicing pain coping skills will be measured by a question scale 0-5. Higher scores denote better outcomes.

  7. Participant overall satisfaction on web-based CBT program [ Time Frame: Up to Week 16 ]
    This refers to the adoption or extent of participants' motivation to engage in the web-based CBT program. Recorded in a question - scale 0-5. Higher scores denote better outcomes.

  8. Nurse's time [ Time Frame: Up to Week 16 ]
    This refers to the feasibility of the web-based CBT program. The number of minutes a nurse spends on study-related phone calls and the time a nurse spends during the initial and ongoing MI training will be recorded.

  9. Perceived Work Rating [ Time Frame: Up to Week 16 ]
    This refers to the feasibility of the web-based CBT program. Nurses will rate perceived additional work load. Recorded using sing a scale 1-5, higher scores denotes worse outcomes.

  10. MITI (motivational interviewing treatment integrity) scale [ Time Frame: Up to Week 16 ]
    This refers to the feasibility of the web-based CBT program. This scale is used to assess treatment fidelity to the principles of MI.Scale range from 5 to 25, where a score of 25 represents 100% adherence to the principles of motivational interviewing (MI).

  11. Mean opioid daily dose [ Time Frame: Up to Week 16 ]
    This refers to the burden or utilization of health care in relation to the web-based CBT program. The mean daily dose of opioids will be recorded for all participants.

  12. Non-study phone calls [ Time Frame: Up to Week 16 ]
    This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of pain relevant phone calls will be recorded.

  13. New referrals to other musculoskeletal-related specialties [ Time Frame: Up to Week 16 ]
    This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of new referrals to other musculoskeletal-related specialties will be recorded.

  14. Number of emergency room visits related to pain [ Time Frame: Up to Week 16 ]
    This refers to the burden or utilization of health care in relation to the web-based CBT program. The number of ER visits per subject related to pain will be recorded.

  15. PROMIS physical health -Fatigue [ Time Frame: Up to Week 16 ]
    This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe fatigue.

  16. PROMIS physical health - Physical function [ Time Frame: Up to Week 16 ]
    This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe physical impairment.

  17. PROMIS physical health - Sleep-related impairment [ Time Frame: Up to Week 16 ]
    This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment.

  18. PROMIS physical health- Pain behavior [ Time Frame: Up to Week 16 ]
    This is a questionnaire that pertains to subject physical health. Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior.

  19. PROMIS social health [ Time Frame: Up to Week 16 ]
    This is a questionnaire that pertains to subject social health. Raw summed score range from 4 to 20, where 20 represents complete inability to participate in various social functions.

  20. BPI (brief pain inventory) pain severity [ Time Frame: Up to Week 16 ]
    This is a pain severity questionnaire. BPI consists of four items that are scored from 0 (no pain) to 10 (worst possible pain); the mean of this four areas is reported as the score.

  21. BPI (brief pain inventory) pain interference [ Time Frame: Up to Week 16 ]
    This is a questionnaire that shows a subject's perceived interference of pain in his/her daily life. The BPI pain interference section consists of seven items that are scored from 0 (no interference) to 10 (complete interference).A pain interference score is calculated from the mean of the seven pain interference items.

  22. Pain Catastrophizing Score (PCS) [ Time Frame: Up to Week 16 ]
    This questionnaire shows the subject's perceived pain. The score is from 0-52 with 0 being the best outcome and 52 being the worst outcome.

  23. Global Rating of Change (GRoC) [ Time Frame: Up to Week 16 ]
    This questionnaire shows how the subject rates his/her overall condition of pain from the beginning of treatment to when the questionnaire is completed. The score ranges from -5 to 5, with -5 being the worst outcome and 5 being the best outcome.

  24. Patient Health Questionnaire Depression Scale (PHQ-8) [ Time Frame: Up to Week 16 ]
    A questionnaire that shows patient's level of depression. Scores can be 0-24, with 0 being the best outcome and 24 being the worst. A score of 10 or greater is considered major depression. A score of 20 or more is severe major depression.

  25. Generalized Anxiety Disorder (GAD-7) [ Time Frame: Up to Week 16 ]
    A questionnaire that shows how much anxiety a subject has. Scores can be 0-18. A score of 5-9 means mild anxiety. A score of 10-14 means moderate anxiety. A score of 15-18 means severe anxiety.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: -

  1. patients at the primary care or rheumatology clinic with daily pain for 6 months or longer affecting the low back, neck, hip, knee or widespread pain;
  2. at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
  3. at least 18 years of age;
  4. reliable phone (landline or cell), and
  5. have home computer with reliable internet access.

Exclusion Criteria:

  1. planned elective surgery during the study period;
  2. very severe symptoms of depression (i.e., PHQ8 score of ≥ 20);
  3. ongoing unresolved disability claims;
  4. inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
  5. cancer-related musculoskeletal pain;
  6. history of bipolar disorder or schizophrenia; and
  7. takes daily opioid for more than one year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927846


Contacts
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Contact: Dennis Ang, M.D. 336-713-4504 dang@wakehealth.edu
Contact: Judy Hooker, A.A.S. 336-716-0186 jhooker@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Dennis Ang, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03927846    
Other Study ID Numbers: IRB00056912
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: If nurse guided web-based CBT can be shown to be effective and implementable, Wake Baptist can potentially leverage web-based CBT as one component in a multidisciplinary pain management program to prospective employers in North Carolina. With assistance from Wake Forest Innovation, Wake Baptist may also develop its own web-based CBT that can be commercialize in the future.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations