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Completed

NCT Number: NCT04441086

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health West Hospital, Avon, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

emotion

Behavioral

Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials.

Healthy Living Active Control

Behavioral

The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse.

Primary outcomes

  1. 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

  1. Change in Depression Symptoms

    Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks

    Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)

  2. Change in Anxiety Symptoms

    Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks

    Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)

  3. Change in Pain Symptoms

    Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks

    Pain will be measured with the Brief Pain Inventory

  4. Change in Sleep efficiency

    Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks

    Sleep efficiency will be a calculation of the ratio of the total sleep time to time spent in bed using the ActiGraph wGT3X-BT accelerometer

  5. Change in Fatigue Symptoms

    Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks

    Fatigue will be measured using the Fatigue Severity Scale

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Jonas Philanthropies
  • Sigma Theta Tau International Honor Society of Nursing

Registry information

Acronym: eMotion

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2020
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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