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Cognitive Behavioral Therapy for Chronic Pain

N/A
Recruiting
Led By Donald J McGeary, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presenting with a chronic pain complaint (pain occurring more days than not over the past three months that is ongoing at the time of baseline evaluation)
DoD/MHS beneficiary (including active duty service members, veterans, and family members) age 18 and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3- and 12-month follow-up assessments
Awards & highlights

Study Summary

This trial will assess whether monthly booster contacts improve long-term outcomes for people with chronic pain who receive BCBT-CP. 716 Military Health Systems beneficiaries will be randomly assigned to standard BCBT-CP or standard BCBT-CP with booster contacts. Patients will be assessed 3, 6, 12, and 18 months after their first BCBT-CP appointment.

Who is the study for?
This trial is for Military Health System beneficiaries over 18 with chronic pain more often than not in the past three months. They must understand English, be referred by a primary care provider, and consent to participate. Those planning surgery or with other health priorities that prevent attendance are excluded.Check my eligibility
What is being tested?
The study tests if adding monthly booster contacts improves long-term outcomes of Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) compared to BCBT-CP alone. Participants will either receive standard therapy or therapy plus boosters and will be evaluated up to 18 months post-treatment.See study design
What are the potential side effects?
Since this intervention involves cognitive behavioral therapy rather than medication, typical drug side effects are not expected. However, participants may experience emotional discomfort discussing painful experiences during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing pain most days for the past three months.
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I am over 18 and part of the DoD/MHS community.
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I have had chronic pain for more than three months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3- and 12-month follow-up assessments
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3- and 12-month follow-up assessments for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral Health Measure-20 (BHM-20)
Defense and Veterans Pain Rating Scale (DVPRS)
Secondary outcome measures
Pain
Insomnia Severity Index (ISI)
Modified Oswestry Disability Index (ODI)
+3 more
Other outcome measures
Alcohol Use Disorders Identification Test (AUDIT-C)
Effect of Coronavirus Pandemic Questionnaire
Electronic Health Record Review
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard BCBT-CP with Telephone BoosterExperimental Treatment2 Interventions
Participants will receive standard BCBT-CP as described in the Standard BCBT-CP arm. They will also receive telephone or video teleconference booster contacts as follows: BCBT-CP Booster Contacts are intended to refresh BCBT-CP content without introducing new skills. To accomplish this, Booster Contacts are manualized (see appended Booster Protocol form) to cover assessment of pain since last contact, review of most recent BCBT-CP module(s) and reminder about the next BCBT-CP appointment (if one is scheduled).
Group II: Standard BCBT-CPActive Control1 Intervention
Brief Cognitive Behavior Therapy for Chronic Pain (BCBT-CP) is a seven-module intervention for chronic pain based on the efficacious specialty-care, ten-session version of this treatment called Cognitive Behavioral Therapy for Chronic Pain (CBT-CP).

Find a Location

Who is running the clinical trial?

Defense Health AgencyFED
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
90,694 Total Patients Enrolled
5 Trials studying Chronic Pain
293 Patients Enrolled for Chronic Pain
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
90,897 Total Patients Enrolled
1 Trials studying Chronic Pain
80 Patients Enrolled for Chronic Pain

Media Library

Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) Clinical Trial Eligibility Overview. Trial Name: NCT04680000 — N/A
Chronic Pain Research Study Groups: Standard BCBT-CP, Standard BCBT-CP with Telephone Booster
Chronic Pain Clinical Trial 2023: Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) Highlights & Side Effects. Trial Name: NCT04680000 — N/A
Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04680000 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are partaking in this clinical research?

"Affirmative. According to the clinicaltrials.gov data, this investigation is currently recruiting participants; with its first posting on August 17th 2021 and last edit on August 26th 2022. The trial requires 716 patients from 5 distinct sites."

Answered by AI

What are the primary goals of this experiment?

"This clinical trial will span 18 months and evaluate the impact of its intervention using Defense and Veterans Pain Rating Scale (DVPRS), which aims to measure pain. Secondary outcomes include assessing changes in scores on a Thirteen-item self-report measure of pain coping – Pain Catastrophizing Scale (PCS) ranging from 0 to 52, Five-item self-report measure of sleep disturbance and insomnia – Insomnia Severity Index (ISI) scored between 1 to 4, and Ten-item self report assessment of pain related disability - Modified Oswestry Disability Index (ODI)."

Answered by AI

Are there still openings available in this experiment?

"According to clinicaltrials.gov, the medical research project initially posted on August 17th 2021 is still actively recruiting participants. The listing has been updated as recently as August 26th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Texas
How old are they?
18 - 65
What site did they apply to?
Uniformed Services University for the Health Sciences
University of Texas Health Science Center San Antonio
Carl R. Darnall Army Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
~22 spots leftby Jun 2024