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

160 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. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Mindfulness-Based Cognitive Therapy for Heart Disease?

Research shows that mindfulness-based cognitive therapy (MBCT) can help reduce stress and improve psychological well-being in people with heart disease and other conditions like cancer. This suggests that MBCT might be beneficial for heart disease patients by addressing stress and emotional challenges. ^{1 2 3 4 5}

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

Research indicates that Mindfulness-Based Cognitive Therapy (MBCT) is generally safe for humans, with no reported adverse events in studies involving individuals with depressive symptoms and chronic diseases. ^{6 7 8 9 10}

How does the treatment MBCT-T for heart disease differ from other treatments?

Mindfulness-Based Cognitive Therapy for Heart Disease (MBCT-T) is unique because it combines mindfulness practices with cognitive therapy techniques to address the psychological aspects of heart disease, unlike traditional treatments that primarily focus on physical symptoms and medical interventions. ^{11 12 13 14 15}

What is the purpose of this trial?

This study was designed using the Multiphase Optimization Strategy (MOST) framework to determine whether two supplemental components increase the efficacy of a mindfulness-based cognitive therapy program delivered via telephone (MBCT-T) for psychological distress. Specifically, this study will test mindfulness booster sessions to follow a standard 8-week MBCT-T intervention, as well as website support in patients with heart disease and/or heart disease risk factors.

Research Team

Tanya Spruill, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

Mild or greater anxiety (GAD-7 score ≥5)

Patients meeting one of the following criteria:

Elevated stress (PSS-10 score ≥15)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of mindfulness-based interventions for patients with coronary heart disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Predictors and moderators of outcomes in mindfulness-based cognitive therapy intervention for early breast cancer patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based stress reduction and mindfulness based cognitive therapy in vascular disease: A systematic review and meta-analysis of randomised controlled trials. [2022]

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

Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial. [2023]

5. England 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. [2019]

6. 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]

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

Mindfulness-based cognitive therapy for depression: trends and developments. [2020]

9. Denmark pubmed.ncbi.nlm.nih.gov

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

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

Effectiveness of mindfulness-based cognitive therapy as an adjuvant to pharmacotherapy in patients with panic disorder or generalized anxiety disorder. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Mitral valve disease--current management and future challenges. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Transcatheter mitral valve replacement: current status]. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Isolated annuloplasty in elderly patients with secondary mitral valve regurgitation: short- and long-term outcomes with a less invasive approach. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Guideline directed medical therapy and reduction of secondary mitral regurgitation. [2022]