MBCT-T for Preoperative Pain

Recruiting at 1 trial location

Overseen By Lisa Doan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Bipolar, Borderline personality, PTSD, others

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

Compensation: Varies

Number of Visits: 4

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how mindfulness-based cognitive therapy, delivered over the phone, can help reduce pain in individuals preparing for spine surgery. It includes weekly sessions before the surgery and follow-up check-ins to assess participants' progress. The study seeks individuals scheduled for lumbar spine surgery who frequently experience anxiety about pain. Participants must have access to a phone and the internet. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance pain management strategies for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for preoperative pain management?

Research has shown that Telephone-Delivered Mindfulness-Based Cognitive Therapy (MBCT-T) is generally safe and well-tolerated by participants. Past studies demonstrated that this method reduces symptoms of depression without significant side effects, suggesting it is likely safe for most people.

This treatment combines mindfulness meditation with cognitive-behavioral techniques. These methods have been safely used in various formats, including over the phone and online. No major negative effects were reported in these studies.

Since MBCT-T focuses on mindfulness and cognitive therapy, it does not involve medication or invasive procedures, enhancing its safety. Participants usually find it acceptable and manageable, indicating it is a safe option for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard pain management options for preoperative pain, which often involve medications like opioids or NSAIDs, the Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) offers a completely different approach. This treatment is unique because it focuses on addressing high pain catastrophizing through mindfulness and cognitive therapy techniques, delivered conveniently over the phone. Researchers are excited about MBCT-T because it not only reduces the need for medication but also empowers patients with skills to manage their pain more effectively. This method could potentially improve surgical outcomes and enhance recovery by targeting the psychological aspects of pain.

What evidence suggests that Telephone-Delivered Mindfulness-Based Cognitive Therapy might be an effective treatment for preoperative pain?

Research has shown that Mindfulness-Based Cognitive Therapy over the phone (MBCT-T), which participants in this trial will receive, can help reduce symptoms of depression. One study found it practical and well-received by people with depression. Additionally, online group mindfulness therapy has effectively treated long-term low back pain. This suggests that mindfulness practices might help manage different types of pain and related stress. Although data on pain before surgery is limited, the therapy's success in similar areas offers hope for its potential effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Lisa Doan, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults with high pain catastrophizing who are scheduled for specific lumbar spine surgeries and require an inpatient stay. Participants must be able to give informed consent, have telephone and internet access, and score at least 20 on the PCS (a measure of pain-related thoughts). People with certain mental health conditions or cognitive impairments, non-English speakers, or those with recent self-harm/suicidality are not eligible.

Inclusion Criteria

PCS score ≥ 20

Able to provide voluntary informed consent

Telephone access

Exclusion Criteria

History of bipolar disorder

History of borderline personality disorder

History of active post-traumatic stress disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

A focus group is conducted to adapt MBCT-T for use in the study population

1 week

Preoperative Treatment

Participants receive four weekly sessions of preoperative telephone-delivered mindfulness-based cognitive therapy (MBCT-T)

4 weeks

4 sessions (telephone)

Postoperative Follow-up

Participants are monitored for pain outcomes and satisfaction for two weeks postoperatively

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T)

Trial Overview The study is testing a program called Mindfulness-based Cognitive Therapy delivered over the phone (MBCT-T) before surgery to see if it helps manage pain better after spine surgery. The first phase adapts MBCT-T for patients through a small focus group. In the second phase, participants receive four weekly sessions before their operation and are then monitored for two weeks after.

How Is the Trial Designed?

Group I: MBCT-T Experimental Treatment 1 Intervention

Participants with high pain catastrophizing who are scheduled for spine surgery will receive four weekly sessions of preoperative telephone-delivered mindfulness-based cognitive therapy (MBCT-T). They will then be followed for two weeks postoperatively.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Mindfulness-based cognitive therapy (MBCT) is recognized as an effective psychotherapeutic intervention that combines cognitive behavioral therapy with mindfulness meditation, specifically aimed at preventing recurrent major depressive disorder.

Over the past fifteen years, MBCT has gained significant attention and is now recommended in various national clinical guidelines for its potential to prevent depressive episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. Velden, AM., Piet, J., Møller, AB., et al.[2018]

The abbreviated, telephone-delivered mindfulness-based cognitive therapy (MBCT-T) program was found to be feasible and acceptable, with 64% of participants attending at least 4 sessions and 71% completing all assigned home practices.

Participants experienced significant reductions in depressive symptoms (4.09 points lower) and anxiety (3.18 points lower) after the 8-week program, indicating preliminary efficacy for this intervention in individuals with chronic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open Trial of Telephone-Delivered Mindfulness-Based Cognitive Therapy: Feasibility, Acceptability, and Preliminary Efficacy for Reducing Depressive Symptoms. Shallcross, AJ., Duberstein, ZT., Sperber, SH., et al.[2022]

A study involving surgical patients with chronic pain showed that 71% of participants used a mindfulness meditation app at least once during a 6-week period, indicating a strong interest in mindfulness-based interventions (MBIs) for pain management.

Despite the high interest, only 8% of patients adhered to the recommended usage of 10 minutes per day, highlighting the need to identify barriers to compliance in order to effectively implement non-pharmacologic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. Diller, ML., Mascaro, J., Haack, C., et al.[2022]

In a study of 129 women with persistent pain after breast cancer treatment, mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity, confirming its efficacy as a treatment option.

Pain catastrophizing was identified as a key mediator in the effectiveness of MBCT, explaining 78% of the pain reduction effect, suggesting that addressing this factor could enhance the therapy's clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Cognitive Therapy and Persistent Pain in Women Treated for Primary Breast Cancer: Exploring Possible Statistical Mediators: Results From a Randomized Controlled Trial. Johannsen, M., O'Connor, M., O'Toole, MS., et al.[2018]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of depression, based on a systematic review of 11 studies.

The evidence suggests that MBCT is effective for treating mental disorders, particularly in preventing relapse, although the overall methodological quality of the studies was moderate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. Galante, J., Iribarren, SJ., Pearce, PF.[2020]

Mindfulness-based cognitive therapy (MBCT) significantly improves headache outcomes primarily through increased pain acceptance, particularly by engaging in valued activities despite the pain, as shown in a study with 24 participants.

The study found that cognitive factors like pain catastrophizing and headache management self-efficacy did not significantly predict improvements in pain interference, suggesting that the psychological process of acceptance is more crucial in the effectiveness of MBCT for headache management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The mediating role of pain acceptance during mindfulness-based cognitive therapy for headache. Day, MA., Thorn, BE.[2018]

The MIND-PT study is a randomized trial comparing an enriched pain management pathway that integrates physical therapy and mindfulness with usual care for patients undergoing surgery for chronic low back pain, aiming to improve pain management and reduce opioid use.

Participants in the enriched pathway will receive presurgical education and mindfulness training, followed by physical therapy after surgery, with the primary outcome being pain impact measured by the PEG scale and secondary outcome focusing on the time to opioid discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Mindfulness-Based Intervention Integrated with Physical Therapy (MIND-PT) for Postsurgical Rehabilitation After Lumbar Surgery: A Protocol for a Randomized Controlled Trial as Part of the Back Pain Consortium (BACPAC) Research Program. Fritz, JM., Rhon, DI., Garland, EL., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) showed potential benefits for patients with chronic pain and opioid use disorder (OUD), including reduced opioid cravings and improved pain coping strategies, but only four out of 21 invited patients participated in the program.

Barriers to participation included the timing of the intervention and practical difficulties, while positive attitudes towards MBCT and intrinsic motivation were key facilitators; adjusting the timing and offering MBCT online could improve feasibility for more patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for chronic noncancer pain and prescription opioid use disorder: A qualitative pilot study of its feasibility and the perceived process of change. Ellerbroek, H., Hanssen, I., Lathouwers, K., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) significantly reduces the risk of relapse or recurrence of major depressive disorder (MDD) by 34%, based on a meta-analysis of six randomized controlled trials involving 593 participants.

For patients with three or more previous episodes of MDD, MBCT offers a 43% reduction in relapse risk and is at least as effective as maintenance antidepressant medication, highlighting its potential as a valuable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mindfulness-based cognitive therapy for prevention of relapse in recurrent major depressive disorder: a systematic review and meta-analysis. Piet, J., Hougaard, E.[2022]

Mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity in women treated for breast cancer, with a robust effect size (d = 0.61) observed in a study of 129 participants over an 8-week program.

MBCT also improved quality of life and reduced the use of nonprescription pain medication, indicating its potential as an effective pain management strategy for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. Johannsen, M., O'Connor, M., O'Toole, MS., et al.[2022]

A review of 20 studies identified key barriers to adherence to Mindfulness-Based Cognitive Therapy (MBCT) for patients with chronic conditions, including practical factors like time commitments and motivation levels.

Facilitators for adherence included strong connections with group members and the credibility of the intervention, suggesting that addressing these factors could improve patient engagement and outcomes in MBCT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the barriers and facilitators to adherence to mindfulness-based cognitive therapy for those with chronic conditions. Marks, E., Moghaddam, N., De Boos, D., et al.[2023]

Mindfulness-based cognitive therapy (MBCT) was found to be feasible, tolerable, and acceptable for patients with headache pain, based on a pilot randomized controlled trial involving 36 participants.

Compared to a delayed treatment control, MBCT significantly improved self-efficacy and pain acceptance, suggesting it may be an effective intervention for managing headache pain, although changes in daily headache frequency were not significantly different between groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for the treatment of headache pain: a pilot study. Day, MA., Thorn, BE., Ward, LC., et al.[2022]

A study involving 124 adults with chronic pain showed that both computerized mindfulness-based cognitive therapy (MIA) and pain management psychoeducation led to significant improvements in pain interference, acceptance, and catastrophizing, with benefits maintained at a 6-month follow-up.

Participants in the MIA group experienced greater reductions in immediate pain and reported better emotional management and stress coping skills compared to those in the psychoeducation group, highlighting unique advantages of mindfulness-based approaches for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of an Online Mindfulness-based Cognitive Therapy Intervention With Online Pain Management Psychoeducation: A Randomized Controlled Study. Dowd, H., Hogan, MJ., McGuire, BE., et al.[2015]

A systematic review of five trials involving various surgical procedures found that cognitive behavioral therapy (CBT) significantly reduces pain intensity and disability in patients experiencing postsurgical pain.

The review highlights the need for further research to optimize the delivery and efficacy of CBT and explore newer psychological approaches for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Nicholls, JL., Azam, MA., Burns, LC., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-pain-2020-04e71

MBCT-T for Preoperative Pain Research on Telephone-Delivered Mindfulness-Based Cognitive Therapy (MBCT-T) for people with depressive symptoms and hypertension found it to be safe, with no ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35903539/

An Open Trial of Telephone-Delivered Mindfulness-Based ... An Open Trial of Telephone-Delivered Mindfulness-Based Cognitive Therapy: Feasibility, Acceptability, and Preliminary Efficacy for Reducing Depressive Symptoms.

3. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03383-2

The effects of telehealth-delivered mindfulness meditation ... Group, videoconference-delivered CT, BA, and MM are effective for CLBP and can be implemented in clinical practice to improve treatment access.

4. researchprotocols.org researchprotocols.org/2021/8/e30951/

Web- and Mindfulness-Based Intervention to Prevent ... The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital.

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e086287.full

Online mindfulness interventions in the care of people with ... Objective With growing access to the internet, online mindfulness programmes have become more commonly used to manage physical and mental health conditions.

6. researchgate.net researchgate.net/publication/379781073_The_effects_of_telehealth-delivered_mindfulness_meditation_cognitive_therapy_and_behavioral_activation_for_chronic_low_back_pain_a_randomized_clinical_trial

The effects of telehealth-delivered mindfulness meditation, ... This study examined psychosocial pain treatment moderation in a secondary analysis of a trial that compared cognitive therapy (CT), mindfulness- ...