HARP Mindfulness Study

NYU Langone Health

Status: Not yet enrolling

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Booster Mindfulness Sessions; Behavioral: MBCT-T; Behavioral: Website Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05841784

22-01609

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

MBCT-T (Reference)

Active Comparator group

Description:

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

Treatment:

Behavioral: MBCT-T

MBCT-T + Booster Mindfulness Sessions

Experimental group

Description:

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

Treatment:

Behavioral: MBCT-T

Behavioral: Booster Mindfulness Sessions

MBCT-T + Website Support

Experimental group

Description:

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

Treatment:

Behavioral: Website Support

Behavioral: MBCT-T

MBCT-T + Website Support + Booster Mindfulness Sessions

Experimental group

Description:

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

Treatment:

Behavioral: Website Support

Behavioral: MBCT-T

Behavioral: Booster Mindfulness Sessions