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

Emotions Clinical Trial

— eMotion  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04441086
• Other study ID #: 2002325890
• Status: Completed
• Phase: N/A
• Start date: January 12, 2021
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 10, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. First time major cardiac event as documented in medical record;

2. enrolled in cardiac rehabilitation phase II program;

3. living independently; and

4. at least mild symptoms of depression and/or anxiety (determined by standardized measure cutpoints).

Exclusion criteria:

1. does not speak English;

2. major Axis 1 psychiatric diagnosis (e.g. schizophrenia);

3. terminal cancer; and

4. legally blind

Related Conditions & MeSH terms

• Cardiac Event
• Cardiovascular Diseases
• Emotions
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• eMotion
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
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.

Locations

Country	Name	City	State
United States	Indiana University Health West Hospital	Avon	Indiana
United States	Indiana University Health Bedford Hospital	Bedford	Indiana
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Indiana University Health Tipton Hospital	Tipton	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Jonas Philanthropies, Sigma Theta Tau International Honor Society of Nursing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Moderate to Vigorous Physical Activity (MVPA)	Minutes spent in MVPA	1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
Secondary	Change in Depression Symptoms	Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)	Baseline to 12 weeks, 20 weeks, and 52 weeks
Secondary	Change in Anxiety Symptoms	Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)	Baseline to 12 weeks, 20 weeks, and 52 weeks
Secondary	Change in Pain Symptoms	Pain will be measured with the Brief Pain Inventory	Baseline to 12 weeks, 20 weeks, and 52 weeks
Secondary	Change in Sleep efficiency	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	Baseline to 12 weeks, 20 weeks, and 52 weeks
Secondary	Change in Fatigue Symptoms	Fatigue will be measured using the Fatigue Severity Scale	Baseline to 12 weeks, 20 weeks, and 52 weeks