- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04724694
Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans
August 23, 2023 updated by: VA Office of Research and Development
Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functional Outcomes amongPrimary Care Veterans
Chronic pain is very common among primary care Veterans and can seriously impact overall patient functioning and well-being.
Currently, behavioral treatments for pain management are not often provided in primary care because they are designed to be delivered in specialty care settings, such as chronic pain clinics.
To address this gap in care, the proposed study will test if Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) is an effective treatment.
Therefore, the first objective of the proposed study is to conduct a randomized controlled trial of Brief CBT-CP compared to primary care treatment as usual to assess treatment effectiveness by examining changes in pain-related physical activity interference, psychological distress, pain intensity, and other related outcomes.
178 eligible participants will be randomized into either Brief CBT-CP and primary care treatment as usual or primary care treatment as usual only.
Eligible Veterans will include those with chronic musculoskeletal pain and pain-related functional impairment identified from primary care.
Participants assigned to Brief CBT-CP will receive six sessions of treatment in 30-minute appointments.
This intervention will include education and goal setting, activities and pacing, relaxation skills, cognitive coping, and relapse prevention.
Assessments will include validated self-report measures that will take place at pre-treatment (baseline), mid-treatment, post-treatment, and at 6-month follow-up.
The second objective of this study is examine the mechanisms by which Brief CBT-CP leads to improvement in patient outcomes.
Statistical analysis will reveal if changes pain self-efficacy (i.e., perceived ability to manage pain or engage in usual activities despite being in pain) and catastrophizing (i.e., unhelpful, negative though patterns about pain and pain management) lead to improvements in patient functioning.
The third objective of this study will be to explore perceptions of Brief CBT-CP among patients who experience significant improvement in outcomes compared to those who did not experience improvement.
Participants will include up to 40 patients who were treated with Brief CBT-CP.
Participants will be interviewed about key components of the treatment and their perception of effectiveness.
Interview data will be compared to the results of statistical analysis to help understand the mechanisms by which Brief CBT-CP is effective or identify areas for improvement.
Results of this study will provide information needed to determine if Brief CBT-CP should be widely disseminated across VA primary care clinics.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
178
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wade Goldstein, MA
- Phone Number: (716) 862-8901
- Email: wade.goldstein@va.gov
Study Contact Backup
- Name: Gregory P Beehler, PhD
- Phone Number: (716) 862-7934
- Email: Gregory.Beehler@va.gov
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14215-1129
- Recruiting
- VA Western New York Healthcare System, Buffalo, NY
-
Contact:
- Wade Goldstein, MA
- Phone Number: (716) 862-8901
- Email: wade.goldstein@va.gov
-
Contact:
- Gregory P Beehler, PhD
- Phone Number: 716-862-7934
- Email: Gregory.Beehler@va.gov
-
Principal Investigator:
- Gregory P. Beehler, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Veterans age >=18 and <=79 years
- Conversant in English
- A diagnosis of musculoskeletal pain of >three months
- PEG score of >= 4 on pain intensity item and both interference items at screening
- BPI interference and pain intensity score of at least 4.0 at baseline
- If currently prescribed pain medication (other than topicals or NSAIDS), a stable dose in the last two months
- If currently prescribed psychiatric medicine, a stable dose in the last two months
- Established history of VA primary care utilization (i.e., at least one primary care visit in the past year)
Exclusion Criteria:
Current or prior (past 12 months) engagement in psychotherapy or behavioral intervention provided by behavioral medicine services or specialty mental health for chronic pain.
- Medication management through psychiatric services or an on-going course of mental health services for issues other than chronic pain are not excluded.
- Endorsement of imminent suicide risk
- Current significant substance use problems (i.e., alcohol, opioids, benzodiazepines, or other drugs)
- Unstable psychiatric status (e.g., active psychosis, current mania)
- Diagnosed with major or minor neurocognitive disorder
- Unwilling to have treatment sessions audio recorded
- Pending disability claim
- Recent or planned surgical/interventional procedure for pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Brief CBT for Chronic Pain and treatment as usual
Participants will receive Brief CBT-CP in addition to usual primary care treatment.
Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks.
Session one focuses on foundational pain education and the development of treatment goals.
Session two emphasizes balanced engagement in physical activity and pleasurable events.
Session three emphasizes skills training for easily implemented relaxation techniques.
Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain.
Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.
|
Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks.
Session one focuses on foundational pain education and the development of treatment goals.
Session two emphasizes balanced engagement in physical activity and pleasurable events.
Session three emphasizes skills training for easily implemented relaxation techniques.
Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain.
Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.
Other Names:
Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Other Names:
|
Other: Treatment as usual only
Participants assigned to treatment as usual will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
|
Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory -- Interference subscale (BPI-I) to assess change at 12 week follow-up
Time Frame: Baseline, 12-weeks
|
This measure is a validated 7-item subscale that evaluates pain-related interference in daily activities and social and occupational functioning.
Average scores range from 0 to 10, with higher scores indicating higher pain-related interference.
|
Baseline, 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Pain Inventory -- Pain Intensity subscale (BPI-P) to assess change at 12 week follow-up
Time Frame: Baseline, 12-weeks
|
This measure is a validated 4-item subscale that evaluates pain intensity.
Average scores range from 0 to 10, with higher scores indicating worse pain intensity.
|
Baseline, 12-weeks
|
Patient Health Questionnaire -- 9 (PHQ-9) to assess change at 12 week follow-up
Time Frame: Baseline, 12-weeks
|
This 9-item measure of depressive symptoms is validated for use in primary care.
Total scores range from 0 to 27, with higher scores indicating more depression symptoms.
|
Baseline, 12-weeks
|
Scale for Suicide Ideation (SSI) to assess change at 12 week follow-up
Time Frame: Baseline, 12-weeks
|
This measure is 21-items and rates current attitudes, behaviors, and plans to commit suicide.
Average scores range from 0 to 38, with higher scores indicating higher intensity of suicidal ideation.
|
Baseline, 12-weeks
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF) to assess change at 12 week follow up
Time Frame: Baseline, 12-weeks
|
This 26-item abbreviated version of the full-length WHOQOL measure evaluates quality of life in several domains such as social relationships and satisfaction with person-environment interactions.
Scoring is by subscales representing four domains (i.e., physical health, psychological, social relationship, and environment).
Transformed mean scores for each domain range from four to 20, with higher scores indicating greater quality of life in the respective domain.
|
Baseline, 12-weeks
|
Ability to Participate in Social Roles and Activities - short form (APSRA) to assess change at 12 week follow up
Time Frame: Baseline, 12-weeks
|
This 8-item measure was developed to evaluate one's perceived ability to perform usual social roles and activities.
Total scores range from eight to 40, with higher scores indicating better ability to participate in usual activities.
|
Baseline, 12-weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Self-Efficacy Questionnaire (PSEQ) to assess role in mediation at 12 week follow up
Time Frame: 12-weeks
|
This validated measure includes 10-items related to pain-related self-efficacy, such as accomplishing goals and becoming more active.
Total scores range from 0 to 60, with higher scores indicating greater pain-related self-efficacy.
|
12-weeks
|
Pain Catastrophizing Scale (PCS) to assess role in mediation at 12 week follow up
Time Frame: 12-weeks
|
This validated 13-item measure assesses pain-related cognitions such as pain magnification and perceived helplessness.
Total scores range from 0 to 52, with higher scores indicating higher levels of negative pain-related thoughts
|
12-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gregory P. Beehler, PhD, VA Western New York Healthcare System, Buffalo, NY
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
January 14, 2021
First Submitted That Met QC Criteria
January 22, 2021
First Posted (Actual)
January 26, 2021
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 23, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3485-R
- RX003485-01A1 (Other Grant/Funding Number: VA-ORD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
The LDS will contain IPD that underlie results presented in publications.
IPD Sharing Time Frame
IPD will be made available for up to three years starting six months after final publication.
IPD Sharing Access Criteria
Data will be shared upon completion of a written request and within 90 days of a completed Data Use Agreement (DUA).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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