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

Trial Summary

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 data supports the effectiveness of the treatment Telephone-Delivered Mindfulness-based Cognitive Therapy (MBCT-T) for preoperative pain?

Mindfulness-based cognitive therapy (MBCT) has shown positive effects on pain and well-being in patients with chronic pain and opioid use disorder, and mindfulness interventions have been beneficial for pain management in surgical patients. These findings suggest that MBCT-T could be effective for managing preoperative pain. ^{1 2 3 4 5}

Is Telephone-Delivered Mindfulness-Based Cognitive Therapy (MBCT-T) safe for humans?

Research on Telephone-Delivered Mindfulness-Based Cognitive Therapy (MBCT-T) for people with depressive symptoms and hypertension found it to be safe, with no adverse events or need for additional mental health treatment reported. ^{6 7 8 9 10}

How is Telephone-Delivered Mindfulness-Based Cognitive Therapy (MBCT-T) different from other treatments for preoperative pain?

Telephone-Delivered Mindfulness-Based Cognitive Therapy (MBCT-T) is unique because it combines mindfulness meditation with cognitive-behavioral techniques and is delivered over the phone, making it more accessible and convenient for patients compared to traditional in-person therapies. ^{5 11 12 13 14}

What is the purpose of this trial?

This is a two phase study. In phase 1, a focus group (N=5) will be conducted to adapt MBCT-T for use in the study population. In phase 2, a single-arm trial will be conducted examining four, weekly sessions of preoperative MBCT-T in subjects with high pain catastrophizing scheduled for spine surgery (N=20). Subjects will then be followed for two weeks postoperatively.

Research Team

Lisa Doan, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

I am scheduled for a specific back surgery that requires staying in the hospital.

I am scheduled for a minor back surgery involving 1 or 2 levels of my lumbar spine.

PCS score ≥ 20

Exclusion Criteria

History of bipolar disorder

History of borderline personality disorder

History of active post-traumatic stress disorder

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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) 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 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]

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 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 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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

The mediating role of pain acceptance during mindfulness-based cognitive therapy for headache. [2018]

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

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. [2022]

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

Comparison of an Online Mindfulness-based Cognitive Therapy Intervention With Online Pain Management Psychoeducation: A Randomized Controlled Study. [2015]

4. England 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. [2023]

5. United States 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. [2023]

6. Denmark pubmed.ncbi.nlm.nih.gov

[Mindfulness-based cognitive therapy is efficient in the treatment of recurrent depression]. [2018]

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

An Open Trial of Telephone-Delivered Mindfulness-Based Cognitive Therapy: Feasibility, Acceptability, and Preliminary Efficacy for Reducing Depressive Symptoms. [2022]

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

Effects of mindfulness-based cognitive therapy on mental disorders: a systematic review and meta-analysis of randomised controlled trials. [2020]

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

Mindfulness-based cognitive therapy for the treatment of headache pain: a pilot study. [2022]

10. England 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. [2023]

11. United States 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. [2018]

12. United States 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. [2022]

13. United States 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. [2022]

14. New Zealand pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. [2022]