Cognitive Behavioral Therapy for Chronic Pain

No longer recruiting at 1 trial location

Overseen By Lisa B Lochner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Opioid analgesics

Disqualifiers: Oncology treatment, Hospice, Surgery, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a type of talk therapy, Cognitive-Behavioral Therapy for Treatment Seeking (CBT-TS), to help Veterans manage chronic pain without opioids. The researchers aim to determine if this therapy can encourage Veterans to begin and maintain non-drug pain treatments, potentially reducing opioid use. Participants will be divided into two groups: one receiving CBT-TS and the other receiving pain education, both through telehealth sessions. Veterans who have used opioid painkillers for more than six months and experience frequent pain may be well-suited for this trial. As an unphased trial, it offers Veterans the chance to explore innovative pain management strategies that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on Veterans who are already on long-term opioid therapy, so it seems likely that you can continue your current opioid medication while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive-Behavioral Therapy (CBT) is generally safe for people with chronic pain. Studies indicate that CBT helps individuals manage their pain better and improve daily activities without serious side effects.

One study found that CBT changes negative thoughts and behaviors, which can greatly benefit those dealing with chronic pain. This makes it a powerful tool for improving how individuals perceive and handle their pain.

Overall, CBT is well-tolerated and lacks the negative side effects that medications might have. It's important to note that this therapy involves talking and thinking about pain differently, rather than taking drugs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for chronic pain, which often involves medication or physical therapy, Cognitive Behavioral Therapy for Treatment Seeking offers a mental approach by helping patients change their thought patterns related to pain. Another unique feature is its delivery method; both the CBT and pain treatment education are provided via telehealth in a single, approximately 45-minute session, making them accessible and convenient for patients. Researchers are excited about these treatments because they provide a non-invasive and potentially rapid way to manage chronic pain, particularly appealing for those who may not respond well to traditional treatments.

What evidence suggests that this trial's treatments could be effective for chronic pain?

Research has shown that Cognitive-Behavioral Therapy (CBT) can help adults with long-term pain. One study found that CBT lowered pain and depression levels for at least a year. Another study demonstrated that CBT delivered through telehealth effectively manages chronic pain. In this trial, participants will receive either CBT for Treatment Seeking or Pain Treatment Education, both via telehealth. These findings suggest that CBT can help Veterans with chronic pain manage their pain better and rely less on opioids. ^{6 7 8 9 10}

Who Is on the Research Team?

Lisham Ashrafioun, PhD

Principal Investigator

VA Finger Lakes Healthcare System, Canandaigua, NY

Are You a Good Fit for This Trial?

This trial is for English-speaking Veterans who have been on long-term opioid therapy (over 20mg morphine equivalent daily) for chronic pain, experiencing pain most days over the last six months. They must not be undergoing cancer treatment or hospice care, have no recent/upcoming surgeries, and not currently in non-drug pain treatments.

Inclusion Criteria

I have experienced pain on most days for the last six months.

I am a veteran prescribed opioids equivalent to more than 20mg of morphine daily for over 90 days.

You need to have quite a bit of pain and it must really affect your daily life.

Exclusion Criteria

I am a veteran who has had surgery recently or will soon.

I am a veteran and have been in a non-drug pain treatment program recently.

I am a veteran receiving cancer treatment or in hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either CBT-TS or pain treatment education over a single 45-minute telehealth session

1 session

1 visit (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, 1-, 3-, and 6-months post-treatment

6 months

Multiple assessments (telehealth)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy for Treatment Seeking
• Pain treatment education

Trial Overview The study tests Cognitive-Behavioral Therapy for Treatment Seeking (CBT-TS) against an education control to see if it helps Veterans start and stick with psychological interventions for managing chronic pain, potentially reducing reliance on opioids.

How Is the Trial Designed?

Group I: CBT for Treatment Seeking Experimental Treatment 1 Intervention

CBT delivered over the course of 1, \~45 minute session delivered via telehealth.

Group II: Pain Treatment Education Active Control 1 Intervention

Pain treatment education is delivered over the course of 1, \~45 minute session delivered via telehealth

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37417610/

Long-term effects of integrated cognitive behavioral ... Our study suggests that integrated CBT may reduce the scores of PCS, PDAS and BDI, and this effect lasts for at least 1 year.

2. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1200685/full

A systematic review of cognitive behavioral therapy-based ... Traditional CBT has beneficial effects in adults with chronic pain (Williams et al., 2020) and is also effective in patients with emotional ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2023.2283113

Predictors of treatment outcome in cognitive behavioural ... The most commonly reported predictors of CBT outcome, with medium to large effect sizes, were anxiety, depression and negative cognitions about pain and coping.

4. jamanetwork.com jamanetwork.com/journals/jama/article-abstract/2836795

Telehealth and Online Cognitive Behavioral Therapy ... This randomized clinical trial examines the effectiveness of remote, scalable cognitive behavioral therapy–based chronic pain (CBT-CP) ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/11100/efficacy_of_cognitive_behavioral_therapy_for.3.aspx

Efficacy of cognitive behavioral therapy for reducing pain... CBT can improve patients' social participation and pain susceptibility to some extent, but it does not show advantages for managing negative emotions.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7886449/

Integrated cognitive behavioral therapy for chronic pain Though there was no reduction in pain intensity, catastrophic cognition showed statistically significant improvement with a large effect size.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2832235

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... MBT and CBT were associated with safe improvements in pain and functional outcomes among adults affected with refractory, complex, opioid- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8489050/

Cognitive–behavioral therapy for management of mental ... Cognitive–behavioral therapy (CBT) helps individuals to eliminate avoidant and safety-seeking behaviors that prevent self-correction of faulty beliefs.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0022399924002496

A meta-analysis of cognitive restructuring in chronically ill ... Clinically, the findings affirm that cognitive restructuring is a highly effective intervention in managing chronic pain and can be effective in both group and ...

10. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0325122

The effect of cognitive behavioural therapy on pain and ... Results showed that CBT is more effective in reducing pain and disability compared to waiting list/usual care (WL/UC). CBT in conjunction with other active ...