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Clinical Trials/NCT04441086
NCT04441086
Completed
Not Applicable

Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction

Indiana University4 sites in 1 country40 target enrollmentJanuary 12, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Event
Sponsor
Indiana University
Enrollment
40
Locations
4
Primary Endpoint
Change in Moderate to Vigorous Physical Activity (MVPA)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to evaluate early preliminary efficacy of the eMotion intervention in US adults who have experienced a first cardiac event and participating in phase II cardiac rehabilitation.

This study will evaluate early efficacy and evaluate the cognitive processes as intervention response variables. Investigators will also examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), symptoms [depression, anxiety, pain, sleep, and fatigue]), and health related quality of life among adults enrolled in cardiac rehabilitation after a first cardiac event.

Detailed Description

Aim 1: Evaluate early preliminary efficacy of the eMotion intervention Research hypothesis 1. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have greater improvement in these outcomes over time: 1.1. Improved minutes of moderate to vigorous physical activity 1.2. Symptom improvement (depression, anxiety, pain, sleep, and fatigue) 1.3. Health related quality of life. Aim 2: Evaluate the cognitive processes as intervention response variables. Research hypothesis 2. Compared with adults randomized to active healthy living attention control and usual care control groups, adults randomized to eMotion will have: 2.1. Improved emotion regulation (efficiency and strategy use) 2.2. Decreased perceived cardiac threat and general stress 2.3. Improved cognition and motivation Aim 3. Exploratory. Examine the relationships between emotion regulation and other cognitive processes and symptoms (threat and stress, cognition and motivation), and symptoms \[depression, anxiety, pain, sleep, and fatigue\]) among adults enrolled in cardiac rehabilitation after a first major cardiac event.

Registry
clinicaltrials.gov
Start Date
January 12, 2021
End Date
October 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kelly L. Wierenga

Assistant Professor, Nursing

Indiana University

Eligibility Criteria

Inclusion Criteria

  • First time major cardiac event as documented in medical record;
  • enrolled in cardiac rehabilitation phase II program;
  • living independently; and
  • at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints).
  • Exclusion criteria:
  • does not speak English;
  • major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
  • terminal cancer; and
  • legally blind

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Moderate to Vigorous Physical Activity (MVPA)

Time Frame: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks

Minutes spent in MVPA

Secondary Outcomes

  • Change in Fatigue Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
  • Change in Depression Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
  • Change in Anxiety Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
  • Change in Pain Symptoms(Baseline to 12 weeks, 20 weeks, and 52 weeks)
  • Change in Sleep efficiency(Baseline to 12 weeks, 20 weeks, and 52 weeks)

Study Sites (4)

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