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

NCT ID: NCT03927846

Last Updated: 2024-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2021-01-18

Brief Summary

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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

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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.

Conditions

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Chronic Musculoskeletal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
Study coordinator will be blinded to randomization

Study Groups

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Telephone Contact (Nurse)

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

Group Type ACTIVE_COMPARATOR

Nurse-guided Web-based Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

E-mail contact

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

Group Type ACTIVE_COMPARATOR

Nurse-guided Web-based Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Nurse-guided Web-based Cognitive Behavioral Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Ang, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UL1TR001420

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00056912

Identifier Type: -

Identifier Source: org_study_id

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