Mindfulness-Based Cognitive Therapy for Heart Disease

Overseen By Tanya Spruill

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Active suicidal ideation, Psychosis, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether extra support can enhance the effectiveness of mindfulness-based cognitive therapy (MBCT) delivered by phone in reducing stress and psychological distress in individuals with heart disease or risk factors for heart disease. Participants will receive MBCT over the phone, with some also receiving additional mindfulness booster sessions, website support, or both, to determine the most effective combination. This trial suits individuals diagnosed with heart disease or those with risk factors such as high blood pressure, diabetes, or high cholesterol, particularly if they frequently experience stress or mild depression or anxiety. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could enhance well-being.

Will I have to stop taking my current medications?

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 has shown that Mindfulness-Based Cognitive Therapy (MBCT), including its phone-based version (MBCT-T), is generally safe. Studies have found no negative effects in patients with heart disease and related conditions. An open trial found MBCT-T to be practical, well-received, and safe for reducing symptoms like depression and anxiety.

For MBCT-T with additional mindfulness sessions and website support, similar positive results have been observed. The therapy is well-tolerated, with no negative effects reported in studies. Adding extra sessions or website support does not compromise safety.

In summary, previous research has demonstrated that MBCT-T and its variations, including extra sessions and website support, are safe, with no significant side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T) for heart disease because it offers a unique, accessible approach compared to traditional treatments like medication and lifestyle changes. Unlike standard treatments, MBCT-T can be administered remotely, making it convenient for patients who may have mobility issues or live far from medical centers. Moreover, the added booster mindfulness sessions and website support in some variations provide ongoing reinforcement, which could enhance the effectiveness and sustainability of heart health improvements. This approach not only aims to manage physical symptoms but also addresses mental and emotional well-being, potentially leading to better overall health outcomes for heart disease patients.

What evidence suggests that this trial's treatments could be effective for heart disease?

Research has shown that Mindfulness-Based Cognitive Therapy (MBCT) can help people with heart disease manage stress and improve mental health. Studies have found that MBCT significantly reduces stress and depression in these patients. For instance, a review found that mindfulness therapies, including MBCT, effectively reduced stress and depression symptoms in people with blood vessel diseases. Another study found that MBCT helped lower stress levels in women who had a heart attack. This trial will evaluate different approaches to delivering MBCT, including MBCT-T alone, MBCT-T with booster mindfulness sessions, MBCT-T with website support, and MBCT-T with both booster sessions and website support. Overall, MBCT seems promising for supporting mental well-being in people at risk of or living with heart disease. ^{1 5 6 7 8}

Who Is on the Research Team?

Tanya Spruill, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with heart disease or risk factors like high blood pressure, diabetes, or high cholesterol. They should have mild to moderate depression and/or anxiety but no recent hospitalizations for heart issues. Participants must not be in other behavioral trials, have significant cognitive impairments, hearing loss, psychosis, suicidal thoughts, or previous MBCT-T treatment.

Inclusion Criteria

I have risk factors for heart disease but haven't had a heart attack, stroke, or heart failure.

Patients meeting one of the following criteria:

Patients meeting one or more of the following criteria at baseline:

Exclusion Criteria

History of, or current diagnosis of, psychosis

Significant cognitive impairment (noted in the EHR or evident during screening)

I am currently having thoughts about harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week Mindfulness-Based Cognitive Therapy program delivered via telephone

8 weeks

Post-Intervention

Participants may receive booster mindfulness sessions and/or website support

4 weeks

Follow-up

Participants are monitored for psychological distress and other health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Booster Mindfulness Sessions
• MBCT-T
• Website Support

Trial Overview The study tests if adding booster mindfulness sessions and website support can improve the effectiveness of a telephone-based mindfulness program (MBCT-T) for those experiencing psychological distress due to heart disease or its risk factors.

How Is the Trial Designed?

Group I: MBCT-T + Website Support + Booster Mindfulness Sessions Experimental Treatment 3 Interventions

Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to both booster sessions and website support.

Group II: MBCT-T + Website Support Experimental Treatment 2 Interventions

Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support.

Group III: MBCT-T + Booster Mindfulness Sessions Experimental Treatment 2 Interventions

Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions.

Group IV: MBCT-T (Reference) Active Control 1 Intervention

Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

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]

Mindfulness-based cognitive therapy (MBCT) is effective in reducing the risk of depressive relapse by increasing mindfulness and decreasing negative repetitive thoughts, which are key mechanisms of change.

Current research highlights the need for more rigorous comparisons with control conditions to better understand MBCT's specific effects, as well as challenges in training therapists and spreading the therapy more widely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy for depression: trends and developments. MacKenzie, MB., Kocovski, NL.[2020]

Both group face-to-face mindfulness-based cognitive therapy (MBCT) and individual internet-based mindfulness-based cognitive therapy (eMBCT) led to long-term reductions in psychological distress and increases in mental health-related quality of life over a nine-month follow-up period for 245 distressed cancer patients.

Patients who participated in eMBCT reported lower psychological distress compared to those in MBCT, particularly benefiting those with lower baseline mindfulness and conscientiousness, suggesting that eMBCT may be a more effective option for certain individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consolidation and prediction of long-term treatment effect of group and online mindfulness-based cognitive therapy for distressed cancer patients. Cillessen, L., Schellekens, MPJ., Van de Ven, MOM., et al.[2019]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524963/

The efficacy of mindfulness-based intervention for heart ... The primary outcomes are 6 minute walking test (6MWT) and heart rate. Secondary outcomes include stress score, anxiety score, and respiratory ...

2. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101530

Brief Mindfulness-Based Cognitive Therapy in Women With ... In this randomized controlled trial of women with MI, MBCT-Brief was associated with greater 6-month reductions in perceived stress than HDE among participants ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022399914000543

Effectiveness of mindfulness-based stress reduction and ... This is a systematic review of mindfulness therapy for people with vascular disease. Beneficial effects of MBSR and MBCT were observed for stress, depression ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11786073/

Brief Mindfulness-Based Cognitive Therapy in Women With ... MBCT-Brief was associated with greater 6-month reductions in stress than an active control among adherent participants. More frequent ...

5. withpower.com withpower.com/trial/phase-cardiovascular-diseases-5-2023-33c31

Mindfulness-Based Cognitive Therapy for Heart Disease Mindfulness-based cognitive therapy (MBCT) significantly reduces the rate of depression relapse by 40% in patients with three or more previous episodes of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7432959/

Telephone-based mindfulness training to reduce stress in ... A meta-analysis of 43 RCTs in cardiac patients found that overall, psychosocial treatment reduced mortality by 27% over follow-up periods of up to 2 years and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722921000134

An Open Trial of Telephone-Delivered Mindfulness-Based ... An abbreviated and telephone-delivered version of MBCT (MBCT-T) is feasible, acceptable, safe, and potentially efficacious for reducing depressive and anxiety ...

8. mdpi.com mdpi.com/2077-0383/14/5/1703

Mindfulness-Based Cognitive Therapy in Clinical Practice MBCT is a clinical intervention that integrates cognitive therapy with mindfulness practices to prevent depression relapses and improve mental health.