Acute Coronary SyndromePEACEIIINCT02754895
Positive Psychology for ACS Patients: a Factorial Design Study
A study testing Positive Psychology (PP) and Motivational Interviewing (MI) in people with Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This trial is part of a multi-phase study to develop and test positive psychology (PP) interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a factorial design, the investigators will: (a) assess the optimal frequency of exercise completion, (b) determine the utility of 'booster sessions'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Positive Psychology (PP) and Motivational Interviewing (MI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2017
- 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
- Adult patients admitted to MGH or BWH inpatient units
- Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
- Age 18 or older
- Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6
Who cannot join
- Cognitive deficits, assessed with 6-item screen
- Inability to participate in physical activity
- Medical conditions precluding interviews or likely to lead to death within 6 months
- Inability to read/write in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Positive Psychology for Acute Coronary Syndrome Patients: a Factorial Design Study
This trial is part of a multi-phase study to develop and test positive psychology (PP) interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a factorial design, the investigators will: (a) assess the optimal frequency of exercise completion, (b) determine the utility of 'booster sessions' after an initial 8-week intervention, and (c) determine the relative merits of utilizing PP exercises alone versus an intervention combining PP with motivational interviewing (MI).
Read the detailed description
The investigators have completed the intervention development and pilot phases (PEACE and PEACEII), and are now aiming to optimize our PP intervention for the target population prior to testing it in a randomized, controlled trial.
The investigators will recruit patients from MGH and Brigham and Women's Hospital (BWH) inpatient units who are admitted with a primary cardiac diagnosis of ACS. Following the completion of baseline outcome measures, participants will be randomized to one of eight treatment conditions. All participants will complete PP exercises at least weekly and will speak with a study trainer weekly for eight weeks. Those receiving the PP-only intervention (conditions 1, 2, 5, 6) will speak to a study trainer for 30 minutes each week. Participants in Conditions 3, 4, 7, and 8 will be enrolled in a combined PP plus motivational interviewing (MI)/goal setting program. Accordingly, their weekly phone sessions will focus on the PP program for 15 minutes, then the MI/goal setting program for an additional 15 minutes. These calls will be recorded, and a percentage of calls will be reviewed to ensure that the PP and MI/goal setting portions of the intervention are being delivered as described in the protocol and trainer manual. Half of the participants (conditions 1, 3, 5, 7) will be instructed to perform the PP exercises once per week while the other half (conditions 2, 4, 6, 8) will be asked to perform them once daily. Finally, half of the participants (those in conditions 5-8) will receive three additional 'booster' phone sessions during weeks 10, 12, and 14. These sessions will focus on integrating PP-related skills into daily life. For participants in the PP+MI condition, booster sessions also will focus on maintaining the health behavior changes that they made during the main portion of the study.
The PP exercises used in this study were selected based on their superior performance in our pre-pilot research and others' work: Gratitude for Positive Events (Week 1), Using personal strengths (Week 2), Gratitude letter/Expressions of Gratitude (Week 3), Capitalizing on Positive Events (Week 4), Remembering past success/Remembering daily successes (Week 5), Enjoyable and meaningful activities (Week 6), Humor in everyday life (Week 7), and Performing acts of kindness \& Next Steps (Week 8). Participants in conditions 5-8 will have three additional bi-weekly "maintaining your gains" sessions (week 10, 12, and 14) in order to identify favorite exercises, explore the skills derived from doing the exercises, and learn how to integrate the exercises in their daily lives.
For the MI/goal setting portion of the intervention, each session follows the same structure. Study trainers will: (a) ask participants about their health goals, (b) advise them about current health guidelines and/or refer them to their treatment team, (c) assess readiness to set a goal by identifying how important participants feel the goal is, how confident participants are about making a change, and what the participants' pros and cons are for making a change, (d) assist participants in clarifying their goals and problem-solving barriers to reaching those goals, and (e) arrange for the next session by summarizing the participant's plan and scheduling the next session. The structure of the sessions will follow the PP structure according to each condition.
At Weeks 8 and 16, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. Furthermore, at Weeks 8 and 16, participants will wear an ActiGraph step counter for 10 days as a measure of physical activity. At 3 and 6 months post enrollment, a research coordinator will call participants to ask some brief questions concerning their health, well-being, adherence to health behaviors, and the application of positive psychology and motivational interviewing skills in everyday life.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Positive Psychology (PP), Motivational Interviewing (MI)
- Keywords
- acute coronary syndrome, health behavior, factorial design, positive psychology
- Medical subject headings
- Acute Coronary Syndrome, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology (PP)Other
Positive psychology (PP) interventions aim to improve the frequency and intensity of positive emotional experiences. This positive psychology intervention focuses on targeted activities in several domains, including altruism (e.g., performing acts of kindness), gratitude (e.g., systematically recalling positive life events), using one's personal strengths in a deliberate manner, and optimism (e.g., thinking about past successes and applying these skills to the future).
Motivational Interviewing (MI)Other
MI is a goal-oriented, patient-centered approach to helping patients resolve their ambivalence to change their health behaviors.
Each session follows the same structure. Study trainers will: (a) ask participants about their health goals, (b) advise them about current health guidelines and/or refer them to their treatment team, (c) assess readiness to set a goal by identifying how important participants feel the goal is, how confident participants are about making a change, and what the participants' pros and cons for making a change, (d) assist participants in clarifying their goals and problem-solving barriers to reaching those goals, and (e) arrange for the next session by summarizing the participant's plan and scheduling the next session.
| Study group | Role | What they receive |
|---|---|---|
| PP-weekly | Experimental | Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week. Receives: Other: Positive Psychology (PP) |
| PP-daily | Experimental | Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day. Receives: Other: Positive Psychology (PP) |
| Shortened PP-weekly plus MI | Experimental | Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week. Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI) |
| Shortened PP-daily plus MI | Experimental | Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day. Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI) |
| PP-weekly with boosters | Experimental | Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention. Receives: Other: Positive Psychology (PP) |
| PP-daily with boosters | Experimental | Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention. Receives: Other: Positive Psychology (PP) |
| Shortened PP-weekly plus MI + boosters | Experimental | Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention. Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI) |
| Shortened PP-daily plus MI with boosters | Experimental | Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention. Receives: Other: Positive Psychology (PP); Other: Motivational Interviewing (MI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
To assess which components of the intervention (daily vs. weekly exercise completion, booster vs. no booster sessions, PP only vs. PP + MI) are associated with the greatest physical activity measured by the Actigraph accelerometer (steps) at 16 weeks.
Measured: 16 weeks (primary outcome for all analyses)
Secondary outcomes (10)
Change in adherence to health behaviors, main secondary outcome
Measured by the three items from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS)
Measured: Baseline, 8 week, 16 week
Change in self-report adherence to physical activity
Measured by one item from the Medical Outcomes Study-Specific Adherence Scale (MOS SAS) which specifically asks about physical activity.
Measured: Baseline, 8 week, 16 week
Change in positive affect
Measured by the Positive and Negative Affect Schedule (PANAS)
Measured: Baseline, 8 week, 16 week
Change in optimism
Measured by the Life Orientation Test-Revised (LOT-R)
Measured: Baseline, 8 week, 16 week
Change in anxiety
Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, 8 week, 16 week
Change in depression
Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline, 8 week, 16 week
Change in physical function
Measured by the Duke Activity Status Index (DASI)
Measured: Baseline, 8 week, 16 week
Change in health-related quality of life (HRQoL)
Measured by the Short Form 12 (SF-12)
Measured: Baseline, 8 week, 16 week
Change in medication adherence
Measured by self-report
Measured: Baseline, 8 week, 16 week
Change in dietary adherence
Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat
Measured: Baseline, 8 week, 16 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startOct 2014
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
- Investigators
- Jeff Huffman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754895
- Sponsor's protocol ID
- 2014P001756
- Other IDs
- 4R01HL113272-04
- Acronym
- PEACEIII
- Status last verified
- May 2017
- First submitted
- 26 Apr 2016
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Duque L, Brown L, Celano CM, Healy B, Huffman JC. Is it better to cultivate positive affect or optimism? Predicting improvements in medical adherence following a positive psychology intervention in patients with acute coronary syndrome. Gen Hosp Psychiatry. 2019 Nov-Dec;61:125-129. doi: 10.1016/j.genhosppsych.2019.06.001. Epub 2019 Jun 4.
PubMed 31280918Celano CM, Albanese AM, Millstein RA, Mastromauro CA, Chung WJ, Campbell KA, Legler SR, Park ER, Healy BC, Collins LM, Januzzi JL, Huffman JC. Optimizing a Positive Psychology Intervention to Promote Health Behaviors After an Acute Coronary Syndrome: The Positive Emotions After Acute Coronary Events III (PEACE-III) Randomized Factorial Trial. Psychosom Med. 2018 Jul/Aug;80(6):526-534. doi: 10.1097/PSY.0000000000000584.
PubMed 29624523
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Psychology for Acute Coronary Syndrome Patients: a Factorial Design Study
- ClinicalTrials.gov ID
- NCT02754895
- Acronym / sponsor ID
- PEACEIII / 2014P001756
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, health behavior, factorial design, positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2014
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 28 Apr 2016 (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 trial is part of a multi-phase study to develop and test positive psychology (PP) interventions in patients hospitalized for an acute coronary syndrome (ACS).Using a factorial design, the investigators will: (a) assess the optimal frequency of exercise completion, (b) determine the utility of 'booster sessions' after an initial 8-week intervention, and (c) determine the relative merits of utilizing PP exercises alone versus an intervention combining PP with motivational interviewing (MI).
Detailed description
The investigators have completed the intervention development and pilot phases (PEACE and PEACEII), and are now aiming to optimize our PP intervention for the target population prior to testing it in a randomized, controlled trial.
The investigators will recruit patients from MGH and Brigham and Women's Hospital (BWH) inpatient units who are admitted with a primary cardiac diagnosis of ACS. Following the completion of baseline outcome measures, participants will be randomized to one of eight treatment conditions. All participants will complete PP exercises at least weekly and will speak with a study trainer weekly for eight weeks. Those receiving the PP-only intervention (conditions 1, 2, 5, 6) will speak to a study trainer for 30 minutes each week. Participants in Conditions 3, 4, 7, and 8 will be enrolled in a combined PP plus motivational interviewing (MI)/goal setting program. Accordingly, their weekly phone sessions will focus on the PP program for 15 minutes, then the MI/goal setting program for an additional 15 minutes. These calls will be recorded, and a percentage of calls will be reviewed to ensure that the PP and MI/goal setting portions of the intervention are being delivered as described in the protocol and trainer manual. Half of the participants (conditions 1, 3, 5, 7) will be instructed to perform the PP exercises once per week while the other half (conditions 2, 4, 6, 8) will be asked to perform them once daily. Finally, half of the participants (those in conditions 5-8) will receive three additional 'booster' phone sessions during weeks 10, 12, and 14. These sessions will focus on integrating PP-related skills into daily life. For participants in the PP+MI condition, booster sessions also will focus on maintaining the health behavior changes that they made during the main portion of the study.
The PP exercises used in this study were selected based on their superior performance in our pre-pilot research and others' work: Gratitude for Positive Events (Week 1), Using personal strengths (Week 2), Gratitude letter/Expressions of Gratitude (Week 3), Capitalizing on Positive Events (Week 4), Remembering past success/Remembering daily successes (Week 5), Enjoyable and meaningful activities (Week 6), Humor in everyday life (Week 7), and Performing acts of kindness \& Next Steps (Week 8). Participants in conditions 5-8 will have three additional bi-weekly "maintaining your gains" sessions (week 10, 12, and 14) in order to identify favorite exercises, explore the skills derived from doing the exercises, and learn how to integrate the exercises in their daily lives.
For the MI/goal setting portion of the intervention, each session follows the same structure. Study trainers will: (a) ask participants about their health goals, (b) advise them about current health guidelines and/or refer them to their treatment team, (c) assess readiness to set a goal by identifying how important participants feel the goal is, how confident participants are about making a change, and what the participants' pros and cons are for making a change, (d) assist participants in clarifying their goals and problem-solving barriers to reaching those goals, and (e) arrange for the next session by summarizing the participant's plan and scheduling the next session. The structure of the sessions will follow the PP structure according to each condition.
At Weeks 8 and 16, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. Furthermore, at Weeks 8 and 16, participants will wear an ActiGraph step counter for 10 days as a measure of physical activity. At 3 and 6 months post enrollment, a research coordinator will call participants to ask some brief questions concerning their health, well-being, adherence to health behaviors, and the application of positive psychology and motivational interviewing skills in everyday life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PP-weekly | Experimental | Other: Positive Psychology (PP)Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week. |
| PP-daily | Experimental | Other: Positive Psychology (PP)Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day. |
| Shortened PP-weekly plus MI | Experimental | Other: Positive Psychology (PP), Other: Motivational Interviewing (MI)Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week. |
| Shortened PP-daily plus MI | Experimental | Other: Positive Psychology (PP), Other: Motivational Interviewing (MI)Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day. |
| PP-weekly with boosters | Experimental | Other: Positive Psychology (PP)Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per week. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention. |
| PP-daily with boosters | Experimental | Other: Positive Psychology (PP)Participants will receive the positive psychology intervention and will be asked to complete a PP exercise once per day. Participants will also receive three "booster" phone calls following the completion of the 8 week intervention. |
| Shortened PP-weekly plus MI + boosters | Experimental | Other: Positive Psychology (PP), Other: Motivational Interviewing (MI)Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per week. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention. |
| Shortened PP-daily plus MI with boosters | Experimental | Other: Positive Psychology (PP), Other: Motivational Interviewing (MI)Participants will receive a shortened version of the positive psychology intervention in addition to motivational interviewing and will be asked to complete a PP exercise once per day. Participants will also receive three additional "booster" phone calls following the completion of the 8 week intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients admitted to MGH or BWH inpatient units
- Diagnosis of acute coronary syndrome (using established criteria for myocardial infarction or unstable angina; confirmed via medical record and/or patient's treatment team)
- Age 18 or older
- Suboptimal adherence on MOS-SAS: Score < 15 OR Score = 15 with physical activity < 6
Key exclusion criteria (4 listed)
- Cognitive deficits, assessed with 6-item screen
- Inability to participate in physical activity
- Medical conditions precluding interviews or likely to lead to death within 6 months
- Inability to read/write in English
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 Psychology (PP)Positive psychology (PP) interventions aim to improve the frequency and intensity of positive emotional experiences. This positive psychology intervention focuses on targeted activities in several domains, including altruism (e.g., performing acts of kindness), gratitude (e.g., systematically recalling positive life events), using one's personal strengths in a deliberate manner, and optimism (e.g., thinking about past successes and applying these skills to the future). | Other | PP-daily, PP-daily with boosters, PP-weekly, PP-weekly with boosters, Shortened PP-daily plus MI, Shortened PP-daily plus MI with boosters, Shortened PP-weekly plus MI, Shortened PP-weekly plus MI + boosters |
| Motivational Interviewing (MI)MI is a goal-oriented, patient-centered approach to helping patients resolve their ambivalence to change their health behaviors. Each session follows the same structure. Study trainers will: (a) ask participants about their health goals, (b) advise them about current health guidelines and/or refer them to their treatment team, (c) assess readiness to set a goal by identifying how important participants feel the goal is, how confident participants are about making a change, and what the participants' pros and cons for making a change, (d) assist participants in clarifying their goals and problem-solving barriers to reaching those goals, and (e) arrange for the next session by summarizing the participant's plan and scheduling the next session. | Other | Shortened PP-daily plus MI, Shortened PP-daily plus MI with boosters, Shortened PP-weekly plus MI, Shortened PP-weekly plus MI + boosters |
Primary outcome
Physical activity
Time frame: 16 weeks (primary outcome for all analyses)
To assess which components of the intervention (daily vs. weekly exercise completion, booster vs. no booster sessions, PP only vs. PP + MI) are associated with the greatest physical activity measured by the Actigraph accelerometer (steps) at 16 weeks.
10 secondary outcomes
Change in adherence to health behaviors, main secondary outcome
Time frame: Baseline, 8 week, 16 week
Change in self-report adherence to physical activity
Time frame: Baseline, 8 week, 16 week
Change in positive affect
Time frame: Baseline, 8 week, 16 week
Change in optimism
Time frame: Baseline, 8 week, 16 week
Change in anxiety
Time frame: Baseline, 8 week, 16 week
Change in depression
Time frame: Baseline, 8 week, 16 week
Change in physical function
Time frame: Baseline, 8 week, 16 week
Change in health-related quality of life (HRQoL)
Time frame: Baseline, 8 week, 16 week
Change in medication adherence
Time frame: Baseline, 8 week, 16 week
Change in dietary adherence
Time frame: Baseline, 8 week, 16 week
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 1 Jun 2017.
- Derived from this study: PubMed 31280918Duque L, Brown L, Celano CM, Healy B, Huffman JC. Is it better to cultivate positive affect or optimism? Predicting improvements in medical adherence following a positive psychology intervention in patients with acute coronary syndrome. Gen Hosp Psychiatry. 2019 Nov-Dec;61:125-129. doi: 10.1016/j.genhosppsych.2019.06.001. Epub 2019 Jun 4.
- Derived from this study: PubMed 29624523Celano CM, Albanese AM, Millstein RA, Mastromauro CA, Chung WJ, Campbell KA, Legler SR, Park ER, Healy BC, Collins LM, Januzzi JL, Huffman JC. Optimizing a Positive Psychology Intervention to Promote Health Behaviors After an Acute Coronary Syndrome: The Positive Emotions After Acute Coronary Events III (PEACE-III) Randomized Factorial Trial. Psychosom Med. 2018 Jul/Aug;80(6):526-534. doi: 10.1097/PSY.0000000000000584.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jeff Huffman, MD principal investigator
Massachusetts General Hospital
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 (PP) and Motivational Interviewing (MI) in people with Acute Coronary Syndrome, 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 4 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 1 Jun 2017. 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?
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?
Physical activity (time frame: 16 weeks (primary outcome for all analyses)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02754895, which also lists 2 linked publications.
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 1 Jun 2017.