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Completed

NCT Number: NCT03927846

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • 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;
  • at least moderate in average pain severity, defined as a weekly average pain severity score of 5 or greater 24;
  • at least 18 years of age;
  • reliable phone (landline or cell), and
  • have home computer with reliable internet access.

Exclusion criteria

  • planned elective surgery during the study period;
  • very severe symptoms of depression (i.e., The eight-item Patient Health Questionnaire depression scale (PHQ8) score of ≥ 20);
  • ongoing unresolved disability claims;
  • inflammatory arthritis (e.g., lupus, rheumatoid arthritis, ankylosing spondylitis, etc.);
  • cancer-related musculoskeletal pain;
  • history of bipolar disorder or schizophrenia; and
  • takes daily opioid for more than one year.

Treatment and study plan

Nurse-guided Web-based Cognitive Behavioral Therapy

Behavioral

nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.

Primary outcomes

  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

    PROMIS pain interference is a questionnaire that measures interference of pain on subject's life. The possible raw score range is 6-30. The raw score has been converted into a T score. The T score range is from 41.6 to 75.6. A t-score indicates the number of standard deviations away from the mean. A t-score of 50 is equal to the mean of a reference population. Values below 50 indicate pain interference better than the reference population and values above 50 indicate pain interference worse than the reference population.

Secondary outcomes

  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 outcomes

  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 CBT. This would be determined by the number of patients who watched the video from Expectation Management and Medical Information (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. Motivational Interviewing Treatment Integrity (MITI) 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. Brief Pain Inventory (BPI) 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 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Web-based Pain Self-Management: Nurse-Guided

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2019
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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