Ignite Creation Date:
2024-05-06 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02754895
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2016-04-26
Brief Title:
Positive Psychology for ACS Patients a Factorial Design Study
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Positive Psychology for Acute Coronary Syndrome Patients a Factorial Design Study
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEACEIII
Brief 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 ACSUsing 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 Womens 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 MIgoal setting program Accordingly their weekly phone sessions will focus on the PP program for 15 minutes then the MIgoal 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 MIgoal 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 PPMI 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 letterExpressions of Gratitude Week 3 Capitalizing on Positive Events Week 4 Remembering past successRemembering 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 MIgoal 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 andor 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 participants 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
The investigators will recruit patients from MGH and Brigham and Womens 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 MIgoal setting program Accordingly their weekly phone sessions will focus on the PP program for 15 minutes then the MIgoal 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 MIgoal 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 PPMI 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 letterExpressions of Gratitude Week 3 Capitalizing on Positive Events Week 4 Remembering past successRemembering 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 MIgoal 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 andor 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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4R01HL113272-04 | NIH | None | httpsreporternihgovquickSearch4R01HL113272-04 |