Positive Psychology for Acute Coronary Syndrome Patients (PEACE-IV)
6 de mayo de 2020 actualizado por: Jeff C. Huffman, MD, Massachusetts General Hospital
Positive Psychology for Acute Coronary Syndrome Patients: a Randomized, Controlled Pilot Trial
This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes.
The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The initial study visit will occur in-person two weeks after discharge from the hospital.
Participants will meet with a member of the study staff (the study "trainer") and complete self-report questionnaires assessing health behavior adherence and mental and physical health.
Then, participants will be randomized to receive the positive psychology + motivational interviewing or the motivational interviewing health education interventions.
A study interventionist will provide a treatment manual specific to their condition, review the rationale for the initial exercise, and assign the first exercise.
If the participant is in the positive psychology + motivational interviewing condition, the trainer will explain the rationale for both the positive psychology and goal-setting portions of the program, and will be assigned the first exercise.
Similarly, if the participant is randomized into the motivational interviewing health education program, the interventionist will introduce them to the program and assign the first exercise.
Participants in both groups will then be given an accelerometer, which they will be asked to wear for 7 days to ensure that they are comfortable with the device and that useable data can be obtained from the participant.
Participants in both groups will then complete twelve 30-minute weekly phone sessions with a study trainer.
The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment.
Upon the completion of these calls, and again at a final follow-up timepoint at 24 weeks, a blinded member of the study staff will call participants to administer self-report outcome measures.
Participants will also be asked to wear an accelerometer at each of these follow-up timepoints as an objective measure of physical activity, which they will return by mail to the study staff.
Tipo de estudio
Intervencionista
Inscripción (Actual)
69
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adult patients admitted to Massachusetts General Hospital or Brigham and Women's Hospital 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
Exclusion Criteria:
- Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically ill patients in research studies.
- Medical conditions precluding interviews or likely to lead to death within 6 months, determined in consultation with the primary treatment team and cardiology co-investigator.
- Inability to perform moderate to vigorous physical activity, as defined by an inability to walk without aid of an assistive device such as a walker or cane, OR inability to walk at a steady pace for at least 5 minutes without stopping.
- Inability to communicate in English.
- Inability to participate in physical activity
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Psicología Positiva + Entrevista Motivacional
Los participantes realizarán ejercicios semanales de psicología positiva y establecerán sistemáticamente objetivos relacionados con la actividad física.
Los entrenadores del estudio revisarán los ejercicios de psicología positiva por teléfono cada semana y usarán técnicas de entrevistas motivacionales para facilitar el establecimiento de metas.
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Para la parte de psicología positiva de la intervención, el capacitador del estudio (a) revisará el ejercicio de psicología positiva de la semana, (b) discutirá la justificación del ejercicio de psicología positiva de la próxima semana a través de una revisión guiada del manual de psicología positiva, y (c) asigne el ejercicio de psicología positiva de la próxima semana.
Para la parte de la entrevista motivacional, los participantes (a) revisarán su objetivo de actividad física de la semana anterior, (b) discutirán técnicas para mejorar la actividad física y (c) establecerán un objetivo de actividad física para la próxima semana.
Los capacitadores del estudio utilizarán técnicas de entrevistas motivacionales para facilitar el establecimiento de metas.
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Comparador activo: Motivational Interviewing Health Education
Participants will speak on the telephone each week with a study trainer.
During these calls, the trainer will provide education about a health behavior (physical activity, medication adherence, diet, stress reduction) and assign an activity related to one health behavior each week.
Motivational interviewing techniques will be used throughout to facilitate health behavior changes.
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Each week, participants will learn about a different health behavior topic related to cardiac health.
They will also be introduced to motivational interviewing topics in concert with the health behavior education topics.
The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of the PP-MI Based Health Behavior Intervention
Periodo de tiempo: 24 weeks
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Feasibility will be measured by examining the number of completed exercises.
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24 weeks
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Acceptability of the PP-MI Exercises: Utility Score
Periodo de tiempo: Weeks 1-12
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Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful).
Weekly utility ratings were averaged to provide an overall utility score of the exercises.
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Weeks 1-12
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Acceptability of the PP-MI Exercises: Ease Score
Periodo de tiempo: Weeks 1-12
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Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy).
Weekly ratings were averaged to provide an overall ease of the exercises.
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Weeks 1-12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Minutes of Moderate to Vigorous Physical Activity (Actigraph)
Periodo de tiempo: MVPA at 12 weeks and 24 weeks
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ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity.
In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.
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MVPA at 12 weeks and 24 weeks
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Change in Medication Adherence
Periodo de tiempo: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks.
Minimum: 0, Maximum:100.
Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks.
Higher score indicates greater levels of medication adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Dietary Adherence
Periodo de tiempo: Change in score from Baseline to 12 weeks, 24 weeks
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Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat.
Minimum= 0; Maximum= 216.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate lower levels of dietary adherence.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Positive Affect
Periodo de tiempo: Change in score from Baseline to 12 weeks, 24 weeks
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The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect.
(Range: 10-50).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of positive affect.
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Change in score from Baseline to 12 weeks, 24 weeks
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Change in Trait Optimism
Periodo de tiempo: Change in score from baseline to 12 week, 24 week
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Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism.
(Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of optimism.
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Change in score from baseline to 12 week, 24 week
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Change in State Optimism
Periodo de tiempo: Change of score from Baseline to 12 weeks, 24 weeks
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Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation.
Minimum:7, Maximum:35.
The higher number indicates a greater level of optimism.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 weeks, 24 weeks
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Changes in HADS-A Scores
Periodo de tiempo: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.
(Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher levels of anxiety.
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Change in score from Baseline to 12 week, 24 week
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Change in HADS-D Scores
Periodo de tiempo: Change in score from Baseline to 12 week, 24 week
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The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range:
0-21).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate worse outcome (i.e.
greater levels of depression).
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Change in score from Baseline to 12 week, 24 week
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Change in Physical Function
Periodo de tiempo: Change of score from Baseline to 12 week, 24 week
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Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity.
Minimum: 0, Maximum: 58.2.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of functional capacity.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Physical)
Periodo de tiempo: Change of score from Baseline to 12 week, 24 week
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from Baseline to 12 week, 24 week
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Change in SF-12 Scores (Mental)
Periodo de tiempo: Change of score from baseline to 12 and 24 weeks.
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The Medical Outcomes Study Short Form-12 (SF-12) will be used to measure quality of life.
This is an instrument which has been used in multiple cardiac studies in the past.
(SF-12 Mental Composite Score and Physical Composite Score Range: 0-100 each).
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate higher level of health related QoL.
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Change of score from baseline to 12 and 24 weeks.
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Change in Adherence to Health Behaviors
Periodo de tiempo: Change of score from Baseline to 12 week, 24 week
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Three Medical Outcomes Study Specific Adherence Scale (MOS SAS) items assessing medication, diet, and exercise, will be measured individually and as a composite score.
(Range: 3-18) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate better adherence to health behaviors.
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Change of score from Baseline to 12 week, 24 week
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Change in Cardiac Symptoms
Periodo de tiempo: Change of score from Baseline to 12 week, 24 week
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Measured by a checklist taken from the Women and Ischemia Syndrome Evaluation Study (WISE) to assess the presence and intensity of ten cardiac symptoms felt to best capture the range of symptoms experienced by ACS patients.
Minimum: 0, Maximum: 30.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
Higher scores indicate greater levels of cardiac symptoms.
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Change of score from Baseline to 12 week, 24 week
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Change in Physical Activity
Periodo de tiempo: Change of score from Baseline to 12 week, 24 week
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Measured by the self-report International Physical Activity Questionnaire (IPAQ).
The measure asseses the types of intensity of physical activity that people do as part of their daily lives.
All activities are converted to multiples of resting energy expenditure (MET) minutes per week.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.
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Change of score from Baseline to 12 week, 24 week
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Change in Perceived Stress
Periodo de tiempo: Change of score from Baseline to 12 week, 24 week
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Measured by the Perceived Stress Scale (PSS-4) measure.
Minimum: 0, Maximum: 16.
Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks Higher scores indicate greater levels of stress.
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Change of score from Baseline to 12 week, 24 week
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jeff Huffman, MD, Massachusetts General Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de mayo de 2017
Finalización primaria (Actual)
10 de julio de 2018
Finalización del estudio (Actual)
26 de noviembre de 2018
Fechas de registro del estudio
Enviado por primera vez
6 de abril de 2017
Primero enviado que cumplió con los criterios de control de calidad
17 de abril de 2017
Publicado por primera vez (Actual)
20 de abril de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
6 de mayo de 2020
Última verificación
1 de mayo de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01HL113272 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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