Mindfulness Therapy for Chronic Pain

Overseen By Lisham Ashrafioun, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canandaigua VA Medical Center

Disqualifiers: Severe SUD, Schizophrenia, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness-based cognitive therapy (MBCT) can reduce chronic pain and lower the risk of suicide. Participants will attend 10 sessions, each lasting about an hour, focusing on mindfulness techniques. The trial compares MBCT to standard health education to determine which is more effective. Veterans who have experienced pain most days for at least six months and have some level of suicidal thoughts may be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative therapies that could significantly improve quality of life.

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

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

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

Research shows that Mindfulness-Based Cognitive Therapy (MBCT) is generally safe for people with chronic pain. Studies have found that MBCT can reduce pain and improve daily life without causing serious side effects. This therapy usually includes guided sessions with mindfulness exercises, which are mental practices to help individuals stay present and calm.

A review of several studies found that most people tolerate MBCT well. The evidence suggests that any side effects are usually mild and temporary, such as increased awareness of existing pain or emotions. These studies have reported no major health risks linked to MBCT.

Overall, MBCT is considered a safe option for managing chronic pain, making it a promising choice for those interested in alternative therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic pain often involve medications like opioids or NSAIDs, which can come with significant side effects and the risk of dependency. Unlike these standard options, Mindfulness-Based Cognitive Therapy (MBCT) targets chronic pain through mental training. MBCT is unique because it combines mindfulness practices with cognitive therapy to help patients change their relationship with pain, potentially reducing its impact without medications. Researchers are excited about this approach because it empowers patients to manage their pain more independently and could offer a sustainable, side-effect-free alternative to traditional pain management methods. Additionally, the focus on mental techniques may improve overall well-being and quality of life, making it a holistic treatment option.

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

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT), which participants in this trial may receive, can alleviate chronic pain. Studies have found that MBCT helps individuals manage and understand their pain, leading to improved daily functioning and reduced pain disruption. Participants in these studies reported overall improvements, including better mood and mindfulness. The therapy also appears to aid with depression and sleep issues often associated with chronic pain. While further research is needed to understand long-term effects, current evidence supports MBCT as an effective method for managing chronic pain. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for English-speaking veterans, aged 18 or older, who understand the study and have chronic pain affecting their daily life. They must also be at risk of suicide, either having suicidal thoughts recently, a history of such ideation in the past few months, or an attempt within the last six months.

Inclusion Criteria

Understand informed consent

You need to have a high level of pain based on a short questionnaire.

I am a veteran and I speak English.

Exclusion Criteria

I have surgeries planned.

I do not have any uncontrolled medical conditions.

You have plans to harm yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Mindfulness-Based Cognitive Therapy or Health Education over 10 sessions, each lasting approximately 60 minutes

10 weeks

Follow-up

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

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• MBCT

Trial Overview The study is testing Mindfulness-Based Cognitive Therapy (MBCT) to see if it helps reduce problems caused by chronic pain and lowers suicide risk compared to standard Health Education.

How Is the Trial Designed?

Group I: Mindfulness-Based Cognitive Therapy (MBCT) Experimental Treatment 1 Intervention

MBCT delivered over the course of 10, \~60 minute sessions

Group II: Health Education Active Control 1 Intervention

Health education sessions delivered over the course of 10, \~60 minute sessions

Who Is Running the Clinical Trial?

Canandaigua VA Medical Center

Lead Sponsor

Trials

13

Recruited

1,800+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8297331/

Effects of Mindfulness-Based Cognitive Therapy for ... MBCT is effective in reducing many symptoms in patients with chronic pain, although its maintenance needs to be further investigated.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6020018/

A Randomized Controlled Pilot Study on Mindfulness ... Participants who had received MBCT treatment reported a significantly higher subjective impression of clinical improvement (mean=2. 5 or “minimally improved”-“ ...

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

Mindfulness vs Cognitive Behavioral Therapy for Chronic ... Results of the study suggest that both treatments have potential utility in treating adults with refractory CLBP and improving pain, function, and quality-of- ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S152659002500656X

Internet-delivered mindfulness-based cognitive therapy ... The primary outcome was change in pain intensity, and secondary outcomes were pain interference, depression, sleep disturbance, and positive and negative affect ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/13548506.2020.1849746

Mindfulness-Based Cognitive Therapy for Treating Chronic ... MBCT showed short-term efficacious on depressed mood and mindfulness of chronic pain patients. Longer follow-ups, large sample and rigorous RCTs that can be ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33241941/

Mindfulness-Based Cognitive Therapy for Treating Chronic ... The systematic review and meta-analysis aimed to examine the effectiveness and safety of MBCT for patients with chronic pain.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5368208/

Mindfulness Meditation for Chronic Pain: Systematic Review ... We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05286112

NCT05286112 | Mindfulness for Pain and Suicide The proposed study will assess the feasibility and acceptability of a mindfulness-based intervention to reduce functional impairment from chronic pain and risk ...