HARP Mindfulness Study

Официальное название

NYU HARP Telephone-Based Mindfulness Program

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• 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 [Срок оценки: Baseline]
• Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention [Срок оценки: Month 2]
• Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up [Срок оценки: Month 6]

Вторичные конечные точки (12)

• PSS-10 Score at Baseline [Срок оценки: Baseline]
• PSS-10 Score at Post-Intervention [Срок оценки: Month 2]
• PSS-10 Score at Follow-Up [Срок оценки: Month 6]
• PHQ-9 Score at Baseline [Срок оценки: Baseline]
• PHQ-9 Score at Post-Intervention [Срок оценки: Month 2]
• PHQ-9 Score at Follow-Up [Срок оценки: Month 6]
• GAD-7 Score at Baseline [Срок оценки: Baseline]
• GAD-7 Score at Post-Intervention [Срок оценки: Month 2]
• GAD-7 Score at Follow-Up [Срок оценки: Month 6]
• Sleep-Quality Score at Baseline [Срок оценки: Baseline]
• Sleep-Quality Score at Post-Intervention [Срок оценки: Month 2]
• Sleep-Quality Score at Follow-Up [Срок оценки: Month 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT05841784 · 22-01609

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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