- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05841784
HARP Mindfulness Study
NYU HARP Telephone-Based Mindfulness Program
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tanya Spruill
- Phone Number: 646-501-3429
- Email: Tanya.Spruill@nyulangone.org
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: MBCT-T (Reference)
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (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.
|
Experimental: MBCT-T + Booster Mindfulness Sessions
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions.
|
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.
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.
|
Experimental: MBCT-T + Website Support
Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support.
|
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.
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.
|
Experimental: 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.
|
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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. |
Baseline
|
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention
Time Frame: 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. |
Month 2
|
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up
Time Frame: 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. |
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSS-10 Score at Baseline
Time Frame: Baseline
|
The PSS-10 is used to measure perceived stress over the past month.
Items are 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.
|
Baseline
|
PSS-10 Score at Post-Intervention
Time Frame: Month 2
|
The PSS-10 is used to measure perceived stress over the past month.
Items are 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.
|
Month 2
|
PSS-10 Score at Follow-Up
Time Frame: Month 6
|
The PSS-10 is used to measure perceived stress over the past month.
Items are 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.
|
Month 6
|
PHQ-9 Score at Baseline
Time Frame: Baseline
|
The PHQ-9 assesses depressive symptoms in the past two weeks.
Each of the nine items is rated on a four-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.
A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
|
Baseline
|
PHQ-9 Score at Post-Intervention
Time Frame: Month 2
|
The PHQ-9 assesses depressive symptoms in the past two weeks.
Each of the nine items is rated on a four-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.
A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
|
Month 2
|
PHQ-9 Score at Follow-Up
Time Frame: Month 6
|
The PHQ-9 assesses depressive symptoms in the past two weeks.
Each of the nine items is rated on a four-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.
A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
|
Month 6
|
GAD-7 Score at Baseline
Time Frame: Baseline
|
The GAD-7 measures anxiety symptoms in the past 2 weeks.
Each item is rated on a four-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.
A score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
|
Baseline
|
GAD-7 Score at Post-Intervention
Time Frame: Month 2
|
The GAD-7 measures anxiety symptoms in the past 2 weeks.
Each item is rated on a four-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.
A score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
|
Month 2
|
GAD-7 Score at Follow-Up
Time Frame: Month 6
|
The GAD-7 measures anxiety symptoms in the past 2 weeks.
Each item is rated on a four-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.
A score of 8 or greater represents a reasonable cut-point for identifying probable cases of generalized anxiety disorder.
|
Month 6
|
Sleep-Quality Score at Baseline
Time Frame: Baseline
|
Participants will rate their sleep quality over the previous 1-week period using a 5-point Likert scale, where 1 = very poor, 2 = poor, 3 = fair, 4 = good, and 5 = very good.
|
Baseline
|
Sleep-Quality Score at Post-Intervention
Time Frame: Month 2
|
Participants will rate their sleep quality over the previous 1-week period using a 5-point Likert scale, where 1 = very poor, 2 = poor, 3 = fair, 4 = good, and 5 = very good.
|
Month 2
|
Sleep-Quality Score at Follow-Up
Time Frame: Month 6
|
Participants will rate their sleep quality over the previous 1-week period using a 5-point Likert scale, where 1 = very poor, 2 = poor, 3 = fair, 4 = good, and 5 = very good.
|
Month 6
|
Average Sleep Duration at Baseline
Time Frame: Baseline
|
Participants will complete 1 week of sleep assessments to track the amount of sleep per night.
A FitBit watch will also be used to help track sleep duration.
|
Baseline
|
Average Sleep Duration at Post-Intervention
Time Frame: Month 2
|
Participants will complete 1 week of sleep assessments to track the amount of sleep per night.
A FitBit watch will also be used to help track sleep duration.
|
Month 2
|
Average Sleep Duration at Follow-Up
Time Frame: Month 6
|
Participants will complete 1 week of sleep assessments to track the amount of sleep per night.
A FitBit watch will also be used to help track sleep duration.
|
Month 6
|
Patient Reported Outcomes Measurement Information System (PROMIS-10) Score at Baseline
Time Frame: Baseline
|
PROMIS-10 measures physical, mental, and social functioning health.
The raw score is the sum of responses and is converted to a T-score ranging from 0-100 with an average score of 50.
Higher scores indicate greater overall health.
|
Baseline
|
PROMIS-10 Score at Post-Intervention
Time Frame: Month 2
|
PROMIS-10 measures physical, mental, and social functioning health.
The raw score is the sum of responses and is converted to a T-score ranging from 0-100 with an average score of 50.
Higher scores indicate greater overall health.
|
Month 2
|
PROMIS-10 Score at Follow-Up
Time Frame: Month 6
|
PROMIS-10 measures physical, mental, and social functioning health.
The raw score is the sum of responses and is converted to a T-score ranging from 0-100 with an average score of 50.
Higher scores indicate greater overall health.
|
Month 6
|
Seattle Angina Questionnaire (SAQ-7) Score at Baseline
Time Frame: Baseline
|
The 7-item SAQ measures disease-specific health over the prior four weeks in patients with coronary artery disease (CAD).
The SAQ-7 produces a summary score ranging from 0-100, where higher scores indicate better disease specific health status.
|
Baseline
|
SAQ-7 Score at Post-Intervention
Time Frame: Month 2
|
The 7-item SAQ measures disease-specific health over the prior four weeks in patients with CAD.
The SAQ-7 produces a summary score ranging from 0-100, where higher scores indicate better disease specific health status.
|
Month 2
|
SAQ-7 Score at Follow-Up
Time Frame: Month 6
|
The 7-item SAQ measures disease-specific health over the prior four weeks in patients with CAD.
The SAQ-7 produces a summary score ranging from 0-100, where higher scores indicate better disease specific health status.
|
Month 6
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tanya Spruill, PhD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-01609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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