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

NCT03927846 | Completed Results

• 2 other identifiers: IRB00056912UL1TR001420
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Completed Phone Calls

  Up to Week 16

• Completed Learning Modules Per Treatment Arm

  Week 16

Other Outcomes (25)

• Proportion of Subjects With Interest in Pain Self-management

  Up to Week 16

• Proportion of Patients Who Viewed Educational Video

  Up to Week 16

• Proportion of Subjects Who Called the Research Coordinator to Participate in the Study.

  Up to Week 16

Study Arms (2)

Telephone Contact (Nurse)

ACTIVE COMPARATOR

6 regular telephone contacts by nurses who will use a motivational interviewing technique

Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy

E-mail contact

ACTIVE COMPARATOR

6 computer generated email reminders (control arm) over an 8-week period.

Behavioral: Nurse-guided Web-based Cognitive Behavioral Therapy

Interventions

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.

E-mail contact; Telephone Contact (Nurse)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

Results Point of Contact

• Title: Dennis Ang, Primary Investigator
• Organization: Wake Forest Health Sciences

dang@wakehealth.edu

336-705-8701

Study Officials

• Dennis Ang, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study coordinator will be blinded to randomization
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: July 17, 2019
• Primary Completion: January 18, 2021
• Study Completion: January 18, 2021
• Last Updated: November 19, 2024
• Results First Posted: July 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)