Acute Coronary SyndromeNCT01270568
Mind-body Interventions in Cardiac Patients
A study testing Positive Psychology, Relaxation Response and Recollection in people with Acute Coronary Syndrome and Congestive Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Congestive Heart Failure
- What is being tested?
- Positive Psychology, Relaxation Response and Recollection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Hospitalization at Massachusetts General Hospital for an acute coronary syndrome or congestive heart failure
- Able to read/write in English
- Have working home or cellular phone
Who cannot join
- Cognitive disorder
- Medical condition likely to lead to death within 6 months
- Illness leading to inabilty to consent or complete study exercises
- Current or prior participation in positive psychology interventions
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure).
In this study, subjects are randomly assigned to complete 8 positive psychology exercises over 8 weeks, or to complete different exercises in control groups.
We hypothesize that patients who are assigned to the positive psychology tasks will be able to complete the exercises at a high rate, will feel that the exercises were easy to perform, and will have greater improvements of optimism, anxiety, mood, and health-related quality of life than subjects in the control conditions.
- Conditions
- Acute Coronary Syndrome, Congestive Heart Failure
- Being tested
- Positive Psychology, Relaxation Response, Recollection
- Keywords
- positive psychology, cardiovascular disease
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychologyOther
Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states
Relaxation ResponseBehavioural
Daily practice of relaxation response, reviewed on a weekly basis
RecollectionBehavioural
Subjects record daily events on a weekly basis for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychology | Experimental | 8 weekly positive psychology exercises Receives: Other: Positive Psychology |
| Relaxation Response | Active comparator | Meditation-based treatment Receives: Behavioral: Relaxation Response |
| Recollection | Sham comparator | Recollection of daily events, recorded weekly Receives: Behavioral: Recollection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasiblity
Percentage of exercises completed in the 8 week period
Measured: 8 weeks
Secondary outcomes (5)
Optimism
Self-report (on Likert scale) of optimism
Measured: 8 weeks
Happiness
Score on Subjective Happiness Scale Score on Happiness subscale of CES-D
Measured: 8 week
Depression
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: 8 weeks
Anxiety
Hospital Anxiety and Depression Scale--Anxiety subscale
Measured: 8 weeks
Mental-health related quality of life
SF-12 Mental Component Score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270568
- Sponsor's protocol ID
- 2009P002386
- Status last verified
- Jan 2011
- First submitted
- 3 Jan 2011
- Last updated
- 21 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mind-body Interventions in Cardiac Patients
- ClinicalTrials.gov ID
- NCT01270568
- Acronym / sponsor ID
- 2009P002386
- Conditions
- Acute Coronary Syndrome, Congestive Heart Failure
- Keywords
- positive psychology, cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Mar 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 Jan 2011 (estimated)
- 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 is investigating whether a series of psychological exercises, called positive psychology, provides benefit to patients who have been hospitalized for heart disease (an 'acute coronary syndrome' or heart failure).
In this study, subjects are randomly assigned to complete 8 positive psychology exercises over 8 weeks, or to complete different exercises in control groups.
We hypothesize that patients who are assigned to the positive psychology tasks will be able to complete the exercises at a high rate, will feel that the exercises were easy to perform, and will have greater improvements of optimism, anxiety, mood, and health-related quality of life than subjects in the control conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Psychology | Experimental | Other: Positive Psychology8 weekly positive psychology exercises |
| Relaxation Response | Active comparator | Behavioral: Relaxation ResponseMeditation-based treatment |
| Recollection | Sham comparator | Behavioral: RecollectionRecollection of daily events, recorded weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hospitalization at Massachusetts General Hospital for an acute coronary syndrome or congestive heart failure
- Able to read/write in English
- Have working home or cellular phone
Key exclusion criteria (4 listed)
- Cognitive disorder
- Medical condition likely to lead to death within 6 months
- Illness leading to inabilty to consent or complete study exercises
- Current or prior participation in positive psychology interventions
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 |
|---|---|---|
| Positive PsychologyWeekly exercises focused on optimism, gratitude, altruism, and other positive affective states | Other | Positive Psychology |
| Relaxation ResponseDaily practice of relaxation response, reviewed on a weekly basis | Behavioural | Relaxation Response |
| RecollectionSubjects record daily events on a weekly basis for 8 weeks | Behavioural | Recollection |
Primary outcome
Feasiblity
Time frame: 8 weeks
Percentage of exercises completed in the 8 week period
5 secondary outcomes
Optimism
Time frame: 8 weeks
Happiness
Time frame: 8 week
Depression
Time frame: 8 weeks
Anxiety
Time frame: 8 weeks
Mental-health related quality of life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2011.
Related trials for Acute Coronary Syndrome
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Not yet recruitingPhase 4
Comparative Assessment of Inclisiran on Top of Standard of Care Versus Standard of Care Alone for LDL-C Evaluation in Acute Coronary Syndrome Patients in Saudi Arabia
Acute Coronary Syndrome
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology, Relaxation Response and Recollection in people with Acute Coronary Syndrome and Congestive Heart Failure, run by Massachusetts General Hospital 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 Jan 2011. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasiblity (time frame: 8 weeks). 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 21 Jan 2011; AzTrials last refreshed its copy on 31 Oct 2026.