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NCT Number: NCT05841784

HARP Mindfulness Study

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MBCT-T

Behavioral

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.

Booster Mindfulness Sessions

Behavioral

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.

Website Support

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanya Spruill

CONTACT

[email protected]

646-501-3429

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • American Heart Association

Registry information

Official study title

NYU HARP Telephone-Based Mindfulness Program

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 3, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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