NYU HARP Telephone-Based Mindfulness Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
MBCT-T (Reference)
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T).
干预措施: MBCT-T (Behavioral)
MBCT-T + Booster Mindfulness Sessions
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions.
干预措施: MBCT-T (Behavioral)
MBCT-T + Booster Mindfulness Sessions
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions.
干预措施: Booster Mindfulness Sessions (Behavioral)
MBCT-T + Website Support
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support.
干预措施: MBCT-T (Behavioral)
MBCT-T + Website Support
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support.
干预措施: Website Support (Behavioral)
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.
干预措施: MBCT-T (Behavioral)
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.
干预措施: Booster Mindfulness Sessions (Behavioral)
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.
干预措施: Website Support (Behavioral)
结局指标
主要结局
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
时间窗: Baseline
Composite score of 3 questionnaires. The total composite score is the sum of scores from the questionnaires and ranges from 0 to 88; lower scores indicate greater overall health. PSS-10 measures perceived stress over the past month. Items rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores range from 0-40; higher scores indicate greater levels of perceived stress. PHQ-9 assesses depressive symptoms in the past two weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. GAD-7 measures anxiety symptoms in the past 2 weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with recommended cutoffs for mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention
时间窗: Month 2
Composite score of 3 questionnaires. The total composite score is the sum of scores from the questionnaires and ranges from 0 to 88; lower scores indicate greater overall health. PSS-10 measures perceived stress over the past month. Items rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores range from 0-40; higher scores indicate greater levels of perceived stress. PHQ-9 assesses depressive symptoms in the past two weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. GAD-7 measures anxiety symptoms in the past 2 weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with recommended cutoffs for mild (5-9), moderate (10-14), and severe (15-21) anxiety.
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up
时间窗: Month 6
Composite score of 3 questionnaires. The total composite score is the sum of scores from the questionnaires and ranges from 0 to 88; lower scores indicate greater overall health. PSS-10 measures perceived stress over the past month. Items rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores range from 0-40; higher scores indicate greater levels of perceived stress. PHQ-9 assesses depressive symptoms in the past two weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. GAD-7 measures anxiety symptoms in the past 2 weeks. Items rated on a 4-point scale ranging from 0 (not at all) to 3 (nearly every day). Total scores range from 0-21 with recommended cutoffs for mild (5-9), moderate (10-14), and severe (15-21) anxiety.
次要结局
- PSS-10 Score at Follow-Up(Month 6)
- PSS-10 Score at Baseline(Baseline)
- PSS-10 Score at Post-Intervention(Month 2)
- PHQ-9 Score at Baseline(Baseline)
- PHQ-9 Score at Post-Intervention(Month 2)
- GAD-7 Score at Baseline(Baseline)
- Average Sleep Duration at Baseline(Baseline)
- Average Sleep Duration at Post-Intervention(Month 2)
- Average Sleep Duration at Follow-Up(Month 6)
- PHQ-9 Score at Follow-Up(Month 6)
- GAD-7 Score at Follow-Up(Month 6)
- GAD-7 Score at Post-Intervention(Month 2)
- Sleep-Quality Score at Baseline(Baseline)
- Sleep-Quality Score at Post-Intervention(Month 2)
- Sleep-Quality Score at Follow-Up(Month 6)
- PROMIS-10 Score at Post-Intervention(Month 2)
- PROMIS-10 Score at Follow-Up(Month 6)
- SAQ-7 Score at Post-Intervention(Month 2)
- Patient Reported Outcomes Measurement Information System (PROMIS-10) Score at Baseline(Baseline)
- Seattle Angina Questionnaire (SAQ-7) Score at Baseline(Baseline)
- SAQ-7 Score at Follow-Up(Month 6)