Cognitive Behavioral Therapy for Chronic Pain

Recruiting at 5 trial locations

Overseen By Abby Blankenship, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Planned surgery, Informed consent, Other health problems

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 7 weeks

716 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment BCBT-CP Booster for chronic pain?

Research shows that Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) can lead to rapid improvements in pain outcomes and is well-received by patients, with many reporting better pain-related functioning after treatment. Additionally, cognitive behavioral therapy (CBT) has been proven effective for chronic pain across various studies, making it a valuable non-drug treatment option. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Chronic Pain safe for humans?

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) is considered a safe treatment option for managing chronic pain, as it is a non-drug approach and has been used as an alternative to opioid medications. ^{1 2 6 7 8}

What makes Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) unique compared to other treatments for chronic pain?

Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) is unique because it is a shorter, modular form of cognitive behavioral therapy designed to be used in primary care settings, making it more accessible and feasible for patients who might not have access to lengthy treatments in specialty care. ^{1 2 3 9 10}

What is the purpose of this trial?

The purpose of this randomized pragmatic trial is to assess the effect of monthly booster contacts on long-term Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) pain outcomes compared to BCBT-CP without a booster in 716 Military Health Systems (MHS) beneficiaries referred to a Behavioral Health Consultant (BHC) for pain management using BCBT-CP. Patients will be randomly assigned to receive either standard BCBT-CP (working with a BHC in the medical home clinic) or standard BCBT-CP with adjunctive monthly booster contacts. Additionally, patient participants and clinic providers and staff will be offered the opportunity to participate in separate post-treatment Focus Groups using a semi-structured interview format designed to assess the usability, ease of use, perceived effectiveness, helpfulness, and barriers to the pain management intervention. Patient participants will be assessed 3-, 6-, 12- and 18-Months following their first appointment for BCBT-CP. Prospective data will be supplemented by a national data pull in collaboration with the Defense Health Agency and the Uniformed Services University Center for Rehabilitation Sciences Research. Pulled data will include a national deidentified dataset of electronic health record data for all individuals treated in the military health system who had access to a Behavioral Health Consultant for the treatment under study in this trial.

Research Team

Donald J McGeary, PhD

Principal Investigator

UT Health San Antonio

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and part of the DoD/MHS community.

I was referred for cognitive therapy by my primary care doctor.

I am over 18 and part of the DoD/MHS community.

Exclusion Criteria

Experiencing another health problem of higher priority for care or that prohibits ability to attend BCBT-CP or research appointments

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

Inability or unwillingness of individual to give written informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) consisting of seven modules, with each module appointment lasting approximately 30 minutes.

7 weeks

7 visits (in-person or virtual)

Booster Contacts

Monthly booster contacts to refresh BCBT-CP content without introducing new skills, occurring via telephone or video conferencing.

12 months

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-, 6-, 12-, and 18-months following their first appointment for BCBT-CP.

18 months

4 visits (in-person or virtual)

Treatment Details

Interventions

• BCBT-CP Booster
• Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)

Trial Overview 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.

Participant Groups

Group I: Standard BCBT-CP with Telephone Booster Experimental Treatment 2 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-CP Active Control 1 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).

Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) for:

• Chronic pain management

Approved in European Union as Cognitive Behavioural Therapy for Chronic Pain (CBT-CP) for:

• Chronic pain management

Approved in Canada as Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) for:

• Chronic pain management

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Defense Health Agency

Collaborator

Trials

3

Recruited

750+

Uniformed Services University of the Health Sciences

Collaborator

Trials

130

Recruited

91,100+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Defense Health Agency

Collaborator

Trials

1

Recruited

720+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

Brooke Army Medical Center

Collaborator

Trials

134

Recruited

28,100+

C.R.Darnall Army Medical Center

Collaborator

Trials

17

Recruited

5,800+

Findings from Research

Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) shows promising effectiveness in primary care settings, with significant improvements in pain intensity and functional limitations observed by the third appointment among 118 patients.

The most effective components of Brief CBT-CP included psychoeducation, goal setting, pacing, and relaxation training, suggesting that these strategies are beneficial for managing chronic pain without relying on medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. Beehler, GP., Murphy, JL., King, PR., et al.[2020]

The RESOLVE trial is a large-scale, 3-arm randomized control trial designed to compare the effectiveness of telephonic/video and online CBT for chronic pain against usual care, involving diverse populations across urban and rural areas.

This study aims to assess not only the clinical effectiveness of these CBT interventions in reducing pain severity but also their cost-effectiveness, potentially improving access to treatment for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. Mayhew, M., Balderson, BH., Cook, AJ., et al.[2023]

Cognitive-behavioral therapy (CBT) is an effective first-line treatment for chronic pain, supported by numerous randomized controlled trials showing improvements in pain and related issues across various chronic pain syndromes.

Recent innovations in CBT delivery, such as web-based and telephone formats, have expanded its accessibility and effectiveness for diverse populations, including children and older adults, indicating a promising direction for future treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. Ehde, DM., Dillworth, TM., Turner, JA.[2022]

A systematic review of 19 studies on cognitive behavioral therapy (CBT) for chronic pain found that psychological factors like anxiety, depression, and negative thoughts about pain significantly influence treatment outcomes, with medium to large effect sizes.

Sociodemographic factors had only small effects on CBT outcomes and were not consistently replicable, highlighting the need for more research to identify reliable predictors and improve the consistency of study designs in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. Forden, G., Ronaghan, S., Williams, P., et al.[2023]

A survey of 34 primary care patients who underwent Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP) showed that 91% found the treatment content useful and 89% were satisfied with their overall experience.

Patients reported an average improvement in pain-related functioning, indicating that Brief CBT-CP is a promising nonpharmacological treatment option for chronic pain in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' perspectives of brief cognitive behavioral therapy for chronic pain: Treatment satisfaction, perceived utility, and global assessment of change. Beehler, GP., Loughran, TA., King, PR., et al.[2021]

The study will evaluate the effectiveness of monthly telehealth booster contacts in enhancing the outcomes of the Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP) among 716 patients with chronic pain, assessing results at multiple time points (3, 6, 12, and 18 months).

This pragmatic trial aims to determine if these booster contacts can help sustain the benefits of BCBT-CP, which is a nonpharmacological approach to pain management integrated into primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial. Goodie, JL., Kanzler, KE., McGeary, CA., et al.[2022]

A study involving 278 patients with chronic back pain found that an AI-driven cognitive behavioral therapy for chronic pain (AI-CBT-CP) was noninferior to standard telephone CBT-CP, showing similar effectiveness in reducing disability and pain over 6 months.

AI-CBT-CP not only achieved better clinical outcomes for patients but also required less than half the therapist time compared to traditional CBT-CP, suggesting it could improve access to treatment for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Piette, JD., Newman, S., Krein, SL., et al.[2023]

Cognitive Behavioral Therapy (CBT) is effective in addressing various factors that influence chronic low back pain (CLBP), but the term itself is too broad for future research, necessitating specific definitions based on the problems being addressed.

Despite its proven effectiveness, CBT is not widely implemented in clinical practice for CLBP, highlighting the need for early adoption and a public health approach to operationalize these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. Hanscom, DA., Brox, JI., Bunnage, R.[2020]

A study involving 14 patients with chronic pain explored their experiences with a high-intensity cognitive-behavioral therapy (CBT) protocol, which included various innovative techniques like tactile attention-shift training and video feedback.

Patients reported varying levels of helpfulness from different CBT components, with memory work being beneficial for nine patients and visual feedback being very helpful for six, indicating that personalized approaches in CBT may enhance treatment outcomes for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. Kutsuzawa, K., Taguchi, K., Shimizu, E.[2022]

A multidisciplinary pain management program based on cognitive behavioral therapy (CBT) significantly improved health-related quality of life (HRQL) and reduced pain intensity in 113 participants over an 8-week period.

The program also enhanced participants' readiness to change their approach to managing chronic pain, suggesting it can effectively break the cycle of chronic pain by addressing psychosocial factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change--A non-randomized controlled study. Dysvik, E., Kvaløy, JT., Stokkeland, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Brief Cognitive Behavioral Therapy For Chronic Pain: Results From a Clinical Demonstration Project in Primary Care Behavioral Health. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for individuals with chronic pain: efficacy, innovations, and directions for research. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Predictors of treatment outcome in cognitive behavioural therapy for chronic pain: a systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Patients' perspectives of brief cognitive behavioral therapy for chronic pain: Treatment satisfaction, perceived utility, and global assessment of change. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Targeting Chronic Pain in Primary Care Settings by Using Behavioral Health Consultants: Methods of a Randomized Pragmatic Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Defining the Role of Cognitive Behavioral Therapy in Treating Chronic Low Back Pain: An Overview. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Attention and Imagery in Cognitive-Behavioral Therapy for Chronic Pain: An Exploratory Study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The effectiveness of a multidisciplinary pain management programme managing chronic pain on pain perceptions, health-related quality of life and stages of change--A non-randomized controlled study. [2022]