Cardiovascular DiseasesNCT05841784
HARP Mindfulness Study
A study testing MBCT-T, Booster Mindfulness Sessions and Website Support in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- MBCT-T, Booster Mindfulness Sessions and Website Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: NYU HARP Telephone-Based Mindfulness Program
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- MBCT-T, Booster Mindfulness Sessions, Website Support
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBCT-TBehavioural
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 SessionsBehavioural
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 SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBCT-T (Reference) | Active comparator | Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T). Receives: Behavioral: MBCT-T |
| MBCT-T + Booster Mindfulness Sessions | Experimental | Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions. Receives: Behavioral: MBCT-T; Behavioral: Booster Mindfulness Sessions |
| MBCT-T + Website Support | Experimental | Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support. Receives: Behavioral: MBCT-T; Behavioral: Website Support |
| MBCT-T + Website Support + Booster Mindfulness Sessions | Experimental | Participants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to both booster sessions and website support. Receives: Behavioral: MBCT-T; Behavioral: Booster Mindfulness Sessions; Behavioral: Website Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Post-Intervention
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.
Measured: Month 2
Composite Score of 3 Questionnaires: PSS-10; PHQ-9; and GAD-7 at Follow-Up
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.
Measured: Month 6
Secondary outcomes (21)
PSS-10 Score at 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.
Measured: Baseline
PSS-10 Score at Post-Intervention
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.
Measured: Month 2
PSS-10 Score at Follow-Up
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.
Measured: Month 6
PHQ-9 Score at 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.
Measured: Baseline
PHQ-9 Score at Post-Intervention
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.
Measured: Month 2
PHQ-9 Score at Follow-Up
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.
Measured: Month 6
GAD-7 Score at 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.
Measured: Baseline
GAD-7 Score at Post-Intervention
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.
Measured: Month 2
GAD-7 Score at Follow-Up
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.
Measured: Month 6
Sleep-Quality Score at 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.
Measured: Baseline
Sleep-Quality Score at Post-Intervention
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.
Measured: Month 2
Sleep-Quality Score at Follow-Up
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.
Measured: Month 6
Average Sleep Duration at 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.
Measured: Baseline
Average Sleep Duration at Post-Intervention
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.
Measured: Month 2
Average Sleep Duration at Follow-Up
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.
Measured: Month 6
Patient Reported Outcomes Measurement Information System (PROMIS-10) Score at 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.
Measured: Baseline
PROMIS-10 Score at Post-Intervention
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.
Measured: Month 2
PROMIS-10 Score at Follow-Up
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.
Measured: Month 6
Seattle Angina Questionnaire (SAQ-7) Score at 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.
Measured: Baseline
SAQ-7 Score at Post-Intervention
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.
Measured: Month 2
SAQ-7 Score at Follow-Up
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.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start15 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Tanya Spruill, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841784
- Sponsor's protocol ID
- 22-01609
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Tanya.Spruill@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYU HARP Telephone-Based Mindfulness Program
- ClinicalTrials.gov ID
- NCT05841784
- Acronym / sponsor ID
- 22-01609
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MBCT-T (Reference) | Active comparator | Behavioral: MBCT-TParticipants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T). |
| MBCT-T + Booster Mindfulness Sessions | Experimental | Behavioral: MBCT-T, Behavioral: Booster Mindfulness SessionsParticipants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to booster mindfulness sessions. |
| MBCT-T + Website Support | Experimental | Behavioral: MBCT-T, Behavioral: Website SupportParticipants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to website support. |
| MBCT-T + Website Support + Booster Mindfulness Sessions | Experimental | Behavioral: MBCT-T, Behavioral: Booster Mindfulness Sessions, Behavioral: Website SupportParticipants will receive Mindfulness-Based Cognitive Therapy delivered via Telephone (MBCT-T), in addition to both booster sessions and website support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients meeting one of the following criteria:
- Patients meeting one or more of the following criteria at baseline:
- Willing to provide informed consent and comply with all aspects of the protocol
- Able to read and communicate in English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBCT-TMBCT-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. | Behavioural | MBCT-T (Reference), MBCT-T + Booster Mindfulness Sessions, MBCT-T + Website Support, MBCT-T + Website Support + Booster Mindfulness Sessions |
| Booster Mindfulness SessionsFollowing 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. | Behavioural | MBCT-T + Booster Mindfulness Sessions, MBCT-T + Website Support + Booster Mindfulness Sessions |
| Website SupportParticipants 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. | Behavioural | MBCT-T + Website Support, MBCT-T + Website Support + Booster Mindfulness Sessions |
Primary outcome
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.
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.
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.
21 secondary outcomes
PSS-10 Score at Baseline
Time frame: Baseline
PSS-10 Score at Post-Intervention
Time frame: Month 2
PSS-10 Score at Follow-Up
Time frame: Month 6
PHQ-9 Score at Baseline
Time frame: Baseline
PHQ-9 Score at Post-Intervention
Time frame: Month 2
PHQ-9 Score at Follow-Up
Time frame: Month 6
GAD-7 Score at Baseline
Time frame: Baseline
GAD-7 Score at Post-Intervention
Time frame: Month 2
GAD-7 Score at Follow-Up
Time frame: Month 6
Sleep-Quality Score at Baseline
Time frame: Baseline
Sleep-Quality Score at Post-Intervention
Time frame: Month 2
Sleep-Quality Score at Follow-Up
Time frame: Month 6
Average Sleep Duration at Baseline
Time frame: Baseline
Average Sleep Duration at Post-Intervention
Time frame: Month 2
Average Sleep Duration at Follow-Up
Time frame: Month 6
Patient Reported Outcomes Measurement Information System (PROMIS-10) Score at Baseline
Time frame: Baseline
PROMIS-10 Score at Post-Intervention
Time frame: Month 2
PROMIS-10 Score at Follow-Up
Time frame: Month 6
Seattle Angina Questionnaire (SAQ-7) Score at Baseline
Time frame: Baseline
SAQ-7 Score at Post-Intervention
Time frame: Month 2
SAQ-7 Score at Follow-Up
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Tanya.Spruill@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tanya Spruill, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBCT-T, Booster Mindfulness Sessions and Website Support in people with Cardiovascular Diseases, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanya Spruill (646-501-3429, Tanya.Spruill@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.