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RecruitingNCT05841784

HARP Mindfulness Study

NYU HARP Telephone-Based Mindfulness Program

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
160 (estimated)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALMBCT-TMBCT-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.
BEHAVIORALBooster Mindfulness SessionsFollowing 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.
BEHAVIORALWebsite SupportParticipants 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.

Timeline

Start date
2025-05-15
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2023-05-03
Last updated
2026-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05841784. Inclusion in this directory is not an endorsement.