Recruiting

MBCT-T, Website Support

Sponsor:

NYU Langone Health

Code:

NCT05841784

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MBCT-T

Booster Mindfulness Sessions

Website Support

Study Details

Brief summary:

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.

Conditions

Cardiovascular Diseases

Study ID

NCT05841784

Start date

May 15, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients meeting one of the following criteria:

  • Has a diagnosis of ischemic heart disease (ICD-10 codes I20 - I25) with no cardiac hospitalizations in the past 6 months
  • Has cardiovascular disease risk factors without meeting a diagnosis of ischemic heart disease or having a cardiovascular disease event (heart attack, stroke, heart failure, and/or unstable angina). Cardiovascular disease risk factors include hypertensive diseases (ICD-10 codes I10 - I11, I15 - I16), diabetes (E8 - E13), and/or hyperlipidemia (E78.0 - E78.5, E78.9)
  • Patients meeting one or more of the following criteria at baseline:

  • Elevated stress (PSS-10 score ≥15)
  • Mild to moderate depressive symptoms (PHQ-9 score between 5-14)
  • Mild or greater anxiety (GAD-7 score ≥5)
  • Willing to provide informed consent and comply with all aspects of the protocol
  • Able to read and communicate in English

Exclusion Criteria:

  • Active suicidal ideation
  • History of, or current diagnosis of, psychosis
  • Significant cognitive impairment (noted in the EHR or evident during screening)
  • Significant hearing loss
  • Current participation in another behavioral clinical trial
  • Has received the MBCT-T intervention in a previous clinical trial.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: MBCT-T (Reference)

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

experimental: MBCT-T + Booster Mindfulness Sessions

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

experimental: MBCT-T + Website Support

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

experimental: MBCT-T + Website Support + Booster Mindfulness Sessions

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

Interventions

MBCT-T

MBCT-T is an 8-week group-based program that combines training in mindfulness and cognitive-behavioral therapy to reduce psychological distress and negative emotions. Each weekly 1-hour session will consist of a check-in, discussion, teaching, mindfulness or cognitive behavioral practice or exercise, inquiry by the facilitator, and summary of the at-home practice.

Booster Mindfulness Sessions

Following the standard 8-week MBCT-T program, participants in certain arms will receive monthly MBCT-T booster sessions for 4 months of follow up. Each booster session will be 1 hour long. The sessions will include a concise review and summary of the main MBCT-T sessions.

Website Support

Participants in certain arms will receive continuous intervention support via the use of an online study website. The website will provide quick access to intervention materials and support to encourage participants to complete the at-home practice and apply the content of the MBCT-T program to real life situations.

Primary outcome measure

  • Composite Score of 3 Questionnaires: Perceived Stress Scale 10-item Version (PSS-10); Patient Health Questionnaire 9-Item Version (PHQ-9); and Generalized Anxiety Disorder Questionnaire 7-Item Version (GAD-7) at Baseline [ Time Frame: Baseline ]
  • Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention [ Time Frame: Month 2 ]
  • Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Tanya Spruill

646-501-3429Tanya.Spruill@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-04-17.