Chronic Musculoskeletal Pain
Conditions
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.
Interventions
BEHAVIORALNurse-guided Web-based Cognitive Behavioral Therapy
nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Study coordinator will be blinded to randomization
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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., The eight-item Patient Health Questionnaire depression scale (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity | 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 |
| PROMIS Pain Interference | 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
| Measure | Time frame | Description |
|---|---|---|
| Completed Phone Calls | Up to Week 16 | The number of completed phone calls by the nurse will be recorded. |
| Completed Learning Modules Per Treatment Arm | Week 16 | The number of completed learning modules per treatment arm will be recorded. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ratings of Perceived Disruption | Up to Week 16 | This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures |
| Uptake Rates | 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. |
| Self-report Frequency of Practicing Pain Coping Skills | 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. |
| Participant Overall Satisfaction on Web-based CBT Program | 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. |
| Nurse's Time | 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. |
| Perceived Work Rating | 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. |
| Motivational Interviewing Treatment Integrity (MITI) Scale | 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). |
| Mean Opioid Daily Dose | 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. |
| Non-study Phone Calls | 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. |
| New Referrals to Other Musculoskeletal-related Specialties | 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. |
| Patient Health Questionnaire Depression Scale (PHQ-8) | 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. |
| PROMIS Physical Health -Fatigue | 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. |
| PROMIS Physical Health - Physical Function | 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. |
| PROMIS Physical Health - Sleep-related Impairment | 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. |
| PROMIS Physical Health- Pain Behavior | 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. |
| PROMIS Social Health | 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. |
| Brief Pain Inventory (BPI) Pain Severity | 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. |
| BPI Pain Interference | 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. |
| Pain Catastrophizing Score (PCS) | 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. |
| Global Rating of Change (GRoC) | 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. |
| Generalized Anxiety Disorder (GAD-7) | 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. |
| Number of Emergency Room Visits Related to Pain | 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. |
| Proportion of Subjects With Interest in Pain Self-management | 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? |
| Proportion of Patients Who Viewed Educational Video | 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. |
| Proportion of Subjects Who Called the Research Coordinator to Participate in the Study. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nurse Support Participants received phone-based coaching | 30 |
| Control No contact with the research team | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 11 |
Baseline characteristics
| Characteristic | Control | Total | Nurse Support |
|---|---|---|---|
| Age, Continuous | 51.8 years STANDARD_DEVIATION 20.5 | 52.1 years STANDARD_DEVIATION 17.8 | 52.3 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 58 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PROMIS pain intensity | 6.0 units on a scale STANDARD_DEVIATION 1.9 | 5.9 units on a scale STANDARD_DEVIATION 1.7 | 5.8 units on a scale STANDARD_DEVIATION 1.6 |
| PROMIS pain interference | 62.9 T-Score STANDARD_DEVIATION 6.5 | 62.1 T-Score STANDARD_DEVIATION 7 | 61.2 T-Score STANDARD_DEVIATION 7.4 |
| Sex: Female, Male Female | 23 Participants | 49 Participants | 26 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Up to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse Support | PROMIS Pain Interference | 57.4 T-score | Standard Error 0.9 |
| Control | PROMIS Pain Interference | 57.3 T-score | Standard Error 0.9 |
Primary
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
Time frame: Up to Week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse Support | PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity | 4.4 score on a scale | Standard Error 0.3 |
| Control | PROMIS (Patient Reported-outcomes Measurement Information System) Pain Intensity | 4.7 score on a scale | Standard Error 0.2 |
Secondary
Completed Learning Modules Per Treatment Arm
The number of completed learning modules per treatment arm will be recorded.
Time frame: Week 16
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse Support | Completed Learning Modules Per Treatment Arm | 7 number of learning modules |
| Control | Completed Learning Modules Per Treatment Arm | 8 number of learning modules |
Secondary
Completed Phone Calls
The number of completed phone calls by the nurse will be recorded.
Time frame: Up to Week 16
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nurse Support | Completed Phone Calls | 3.5 number of phone calls |
| Control | Completed Phone Calls | 0 number of phone calls |
Other Pre-specified
BPI Pain Interference
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nurse Support | BPI Pain Interference | 3.5 score on a scale | Standard Error 0.3 |
| Control | BPI Pain Interference | 3.5 score on a scale | Standard Error 0.3 |
Other Pre-specified
Brief Pain Inventory (BPI) Pain Severity
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
Other Pre-specified
Generalized Anxiety Disorder (GAD-7)
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
Other Pre-specified
Global Rating of Change (GRoC)
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
Other Pre-specified
Mean Opioid Daily Dose
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
Other Pre-specified
Motivational Interviewing Treatment Integrity (MITI) Scale
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
Other Pre-specified
New Referrals to Other Musculoskeletal-related Specialties
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
Other Pre-specified
Non-study Phone Calls
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
Other Pre-specified
Number of Emergency Room Visits Related to Pain
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
Other Pre-specified
Nurse's Time
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
Other Pre-specified
Pain Catastrophizing Score (PCS)
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
Other Pre-specified
Participant Overall Satisfaction on Web-based CBT Program
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
Other Pre-specified
Patient Health Questionnaire Depression Scale (PHQ-8)
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
Other Pre-specified
Perceived Work Rating
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
Other Pre-specified
PROMIS Physical Health -Fatigue
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
Other Pre-specified
PROMIS Physical Health- Pain Behavior
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
Other Pre-specified
PROMIS Physical Health - Physical Function
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
Other Pre-specified
PROMIS Physical Health - Sleep-related Impairment
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
Other Pre-specified
PROMIS Social Health
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
Other Pre-specified
Proportion of Patients Who Viewed Educational Video
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
Other Pre-specified
Proportion of Subjects Who Called the Research Coordinator to Participate in the Study.
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
Other Pre-specified
Proportion of Subjects With Interest in Pain Self-management
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
Other Pre-specified
Ratings of Perceived Disruption
This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures
Time frame: Up to Week 16
Other Pre-specified
Self-report Frequency of Practicing Pain Coping Skills
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
Other Pre-specified
Uptake Rates
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