NCT02004158

Brief Summary

In this proof-of-concept study, the investigators will assess the ease and usefulness of a positive psychology program in patients with acute coronary syndrome and less-than-optimal adherence to health behaviors. The investigators believe that positive psychology (a field that studies boosting positive emotions rather than simply reducing negative emotions) will help this cardiac population to be more healthy. The investigators want to determine whether this positive psychology program has the potential to be an adjunctive treatment for cardiac populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 24, 2017

Completed
Last Updated

July 24, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

December 3, 2013

Results QC Date

March 22, 2017

Last Update Submit

May 2, 2017

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndromeHealth behaviorMental health

Outcome Measures

Primary Outcomes (3)

  • Rate of Exercise Completion

    Rate of exercise completion will be measured by the number of participants who have a good rate of completion of exercises. There are 8 exercises in total. A good rate of completion will be defined as an average of 5 or more exercises completed per subject.

    8 weeks

  • Ease of Exercises

    Ease of exercises will be measured by a self-report 10-point Likert scale (0=not easy to complete, 10=very easy to complete). Ease will be defined as an average score of 6 or more on this scale.

    8 weeks

  • Self-reported Psychological Impact of Exercises

    Psychological impact of exercises will be measured by two self-reported 10-point Likert scales. One scale measures optimism after completing the exercise (0=not optimistic, 10=very optimistic), and the other scale measures happiness after completing the exercise (0=not happy, 10=very happy). Psychological impact will be defined as an average score of 6 or more on both of these scales.

    8 weeks

Secondary Outcomes (1)

  • Objective Psychological Impact of Exercises

    8 weeks

Study Arms (1)

Positive psychology

EXPERIMENTAL

Positive psychology intervention

Behavioral: Positive psychology intervention

Interventions

Positive psychology interventionBEHAVIORAL
Positive psychology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients admitted to one of three cardiac inpatient units at Massachusetts General Hospital.
  • Primary diagnosis of acute coronary syndrome (myocardial infarction or unstable angina).
  • Less-than-optimal adherence to health behaviors. This will be defined as a mean score of less than 15 on the Medical Outcomes Study Specific Adherence Scale (scores range from 3-18, with higher scores indicating better adherence).

You may not qualify if:

  • Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.
  • Patients not prescribed aspirin at discharge.
  • Inability to communicate in English.
  • Inability to participate in physical activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acute Coronary SyndromeHealth BehaviorPsychological Well-Being

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesBehaviorPersonal Satisfaction

Results Point of Contact

Title
Jeff Huffman
Organization
Massachusetts General Hospital
jhuffman@partners.org
617-724-2910

Study Officials

  • Jeff Huffman, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Psychiatry Research Program

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 6, 2013

Study Start

November 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 24, 2017

Results First Posted

July 24, 2017

Record last verified: 2017-05

Locations

US(1)