Clinical trial NCT05841784: HARP Mindfulness Study
Official title: NYU HARP Telephone-Based Mindfulness Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-05-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Baseline
measure: Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention
timeFrame: Month 2
measure: Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up
timeFrame: Month 6
Secondary outcomes:
measure: PSS-10 Score at Baseline
timeFrame: Baseline
measure: PSS-10 Score at Post-Intervention
timeFrame: Month 2
measure: PSS-10 Score at Follow-Up
timeFrame: Month 6
measure: PHQ-9 Score at Baseline
timeFrame: Baseline
measure: PHQ-9 Score at Post-Intervention
timeFrame: Month 2
measure: PHQ-9 Score at Follow-Up
timeFrame: Month 6
measure: GAD-7 Score at Baseline
timeFrame: Baseline
measure: GAD-7 Score at Post-Intervention
timeFrame: Month 2
measure: GAD-7 Score at Follow-Up
timeFrame: Month 6
measure: Sleep-Quality Score at Baseline
timeFrame: Baseline
measure: Sleep-Quality Score at Post-Intervention
timeFrame: Month 2
measure: Sleep-Quality Score at Follow-Up
timeFrame: Month 6
measure: Average Sleep Duration at Baseline
timeFrame: Baseline
measure: Average Sleep Duration at Post-Intervention
timeFrame: Month 2
measure: Average Sleep Duration at Follow-Up
timeFrame: Month 6
measure: Patient Reported Outcomes Measurement Information System (PROMIS-10) Score at Baseline
timeFrame: Baseline
measure: PROMIS-10 Score at Post-Intervention
timeFrame: Month 2
measure: PROMIS-10 Score at Follow-Up
timeFrame: Month 6
measure: Seattle Angina Questionnaire (SAQ-7) Score at Baseline
timeFrame: Baseline
measure: SAQ-7 Score at Post-Intervention
timeFrame: Month 2
measure: SAQ-7 Score at Follow-Up
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tanya Spruill, PhD
role: PRINCIPAL_INVESTIGATOR
References: