Brief Cognitive Behavioral Therapy for Chronic Pain to Improve Functioning Among Veterans

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    178
  • sponsor
    VA Office of Research and Development
Updated on 29 August 2023
heat
chronic pain
pain relieving

Summary

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.

Details
Condition Musculoskeletal Pain, Pain
Treatment Treatment As Usual, Brief CBT for Chronic Pain
Clinical Study IdentifierNCT04724694
SponsorVA Office of Research and Development
Last Modified on29 August 2023

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note