Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
Primary Purpose
Chronic Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nurse-guided Web-based Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Musculoskeletal Pain
Eligibility Criteria
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.
Sites / Locations
- Wake Forest Baptist Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Telephone Contact (Nurse)
E-mail contact
Arm Description
6 regular telephone contacts by nurses who will use a motivational interviewing technique
6 computer generated email reminders (control arm) over an 8-week period.
Outcomes
Primary Outcome Measures
PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome
PROMIS Pain Interference
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 Outcome Measures
Completed Phone Calls
The number of completed phone calls by the nurse will be recorded.
Completed Learning Modules Per Treatment Arm
The number of completed learning modules per treatment arm will be recorded.
Full Information
NCT ID
NCT03927846
First Posted
April 23, 2019
Last Updated
June 24, 2021
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03927846
Brief Title
Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
Official Title
Web-based Pain Self-Management: Nurse-Guided
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
January 18, 2021 (Actual)
Study Completion Date
January 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Musculoskeletal Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Study coordinator will be blinded to randomization
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telephone Contact (Nurse)
Arm Type
Active Comparator
Arm Description
6 regular telephone contacts by nurses who will use a motivational interviewing technique
Arm Title
E-mail contact
Arm Type
Active Comparator
Arm Description
6 computer generated email reminders (control arm) over an 8-week period.
Intervention Type
Behavioral
Intervention Name(s)
Nurse-guided Web-based Cognitive Behavioral Therapy
Intervention Description
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.
Primary Outcome Measure Information:
Title
PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity
Description
Questionnaire that measures subject pain intensity. The possible score range is 3-15, 3 being the best outcome and 15 being the worst outcome
Time Frame
Up to Week 16
Title
PROMIS Pain Interference
Description
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.
Time Frame
Up to Week 16
Secondary Outcome Measure Information:
Title
Completed Phone Calls
Description
The number of completed phone calls by the nurse will be recorded.
Time Frame
Up to Week 16
Title
Completed Learning Modules Per Treatment Arm
Description
The number of completed learning modules per treatment arm will be recorded.
Time Frame
Week 16
Other Pre-specified Outcome Measures:
Title
Proportion of Subjects With Interest in Pain Self-management
Description
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?"
Time Frame
Up to Week 16
Title
Proportion of Patients Who Viewed Educational Video
Description
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.
Time Frame
Up to Week 16
Title
Proportion of Subjects Who Called the Research Coordinator to Participate in the Study.
Description
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.
Time Frame
Up to Week 16
Title
Ratings of Perceived Disruption
Description
This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures
Time Frame
Up to Week 16
Title
Uptake Rates
Description
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.
Time Frame
Up to Week 16
Title
Self-report Frequency of Practicing Pain Coping Skills
Description
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.
Time Frame
Up to Week 16
Title
Participant Overall Satisfaction on Web-based CBT Program
Description
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.
Time Frame
Up to Week 16
Title
Nurse's Time
Description
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.
Time Frame
Up to Week 16
Title
Perceived Work Rating
Description
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.
Time Frame
Up to Week 16
Title
Motivational Interviewing Treatment Integrity (MITI) Scale
Description
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).
Time Frame
Up to Week 16
Title
Mean Opioid Daily Dose
Description
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.
Time Frame
Up to Week 16
Title
Non-study Phone Calls
Description
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.
Time Frame
Up to Week 16
Title
New Referrals to Other Musculoskeletal-related Specialties
Description
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.
Time Frame
Up to Week 16
Title
Number of Emergency Room Visits Related to Pain
Description
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.
Time Frame
Up to Week 16
Title
PROMIS Physical Health -Fatigue
Description
This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe fatigue.
Time Frame
Up to Week 16
Title
PROMIS Physical Health - Physical Function
Description
This is a questionnaire that pertains to subject physical health. Raw summed score from 4 to 20, where 20 represents severe physical impairment.
Time Frame
Up to Week 16
Title
PROMIS Physical Health - Sleep-related Impairment
Description
This is a questionnaire that pertains to subject physical health.Raw summed score from 4 to 20, where 20 represents severe sleep impairment.
Time Frame
Up to Week 16
Title
PROMIS Physical Health- Pain Behavior
Description
This is a questionnaire that pertains to subject physical health. Raw summed score from 20 to 100, where 100 represents severely maladaptive pain behavior.
Time Frame
Up to Week 16
Title
PROMIS Social Health
Description
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.
Time Frame
Up to Week 16
Title
Brief Pain Inventory (BPI) Pain Severity
Description
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.
Time Frame
Up to Week 16
Title
BPI Pain Interference
Description
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.
Time Frame
Up to Week 16
Title
Pain Catastrophizing Score (PCS)
Description
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.
Time Frame
Up to Week 16
Title
Global Rating of Change (GRoC)
Description
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.
Time Frame
Up to Week 16
Title
Patient Health Questionnaire Depression Scale (PHQ-8)
Description
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.
Time Frame
Up to Week 16
Title
Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Up to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Ang, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Implementation of Nurse-guided Web-based Cognitive Behavioral Therapy for Pain Management
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