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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

Must not have

Scheduled for a planned pain-related surgery or pain intervention within 6 weeks of enrollment (because the intervention may obscure BCBT-CP outcomes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3- and 12-month follow-up assessments

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a surgery or pain treatment planned within 6 weeks that could affect my trial participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3- and 12-month follow-up assessments

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Behavioral Health Measure-20 (BHM-20)

Defense and Veterans Pain Rating Scale (DVPRS)

Secondary study objectives

Pain

Insomnia Severity Index (ISI)

Modified Oswestry Disability Index (ODI)

+3 more

Other study objectives

Alcohol Use Disorders Identification Test (AUDIT-C)

Effect of Coronavirus Pandemic Questionnaire

Electronic Health Record Review

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

0 / 4Eligibility criteria met