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

Chronic Musculoskeletal Pain Clinical Trial

Official title:

Web-based Pain Self-Management: Nurse-Guided

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927846
• Other study ID #: IRB00056912
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: January 18, 2021

Study information

• Verified date: February 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 18, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Musculoskeletal Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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?"	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	Ratings of Perceived Disruption	This refers to whether health care personnel perceives a disruption in the clinic standard operating procedures	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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).	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
Other	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.	Up to Week 16
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	Up to Week 16
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.	Up to Week 16
Secondary	Completed Phone Calls	The number of completed phone calls by the nurse will be recorded.	Up to Week 16
Secondary	Completed Learning Modules Per Treatment Arm	The number of completed learning modules per treatment arm will be recorded.	Week 16