Cognitive Behavioral Therapy for Chronic Pain

Overseen By Gregory P Beehler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Opioids, Benzodiazepines

Disqualifiers: Substance use, Unstable psychiatric, Neurocognitive disorder, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6-12 weeks

184 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Gregory P. Beehler, PhD

Principal Investigator

VA Western New York Healthcare System, Buffalo, NY

Eligibility Criteria

Veterans aged 18-79 with chronic musculoskeletal pain and functional impairment, conversant in English, stable on any pain or psychiatric meds for two months, and have used VA primary care in the past year. Excluded are those with substance use problems, unstable psychiatric status, pending disability claims, recent psychotherapy for pain, planned surgeries for pain or imminent suicide risk.

Inclusion Criteria

Conversant in English

I am a veteran aged between 18 and 79.

My pain medication dose has been the same for the last two months.

Exclusion Criteria

You have been deemed to be at high risk of attempting to harm yourself.

I have had or will have surgery to manage pain.

I am receiving mental health services not related to chronic pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brief CBT-CP in addition to usual primary care treatment, consisting of six 30-minute sessions over 6-12 weeks

6-12 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6-month follow-up

6 months

Treatment Details

Interventions

• Brief CBT for Chronic Pain
• Treatment as usual

Trial Overview The trial is testing Brief Cognitive Behavioral Therapy (CBT) for Chronic Pain against usual primary care treatments. It aims to see if six sessions of Brief CBT can improve physical activity interference due to pain, psychological distress and other outcomes compared to standard care.

Participant Groups

Group I: Treatment as usual only Experimental Treatment 1 Intervention

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.

Group II: Brief CBT for Chronic Pain and treatment as usual Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+