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

NCT04441086 | Completed DMC

• 1 other identifier: 2002325890
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiac Event; Emotions

Keywords

Emotion regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Change in Fatigue Symptoms

  Baseline to 12 weeks, 20 weeks, and 52 weeks

Study Arms (3)

eMotion

EXPERIMENTAL

The eMotion intervention is based on feasibility testing of the successful in-person program with critical refinement to improve accessibility. eMotion has undergone subsequent content validity testing with intervention development, self-management, cardiovascular health, and health information technology delivery experts. eMotion teaches a carefully selected repertoire of emotion regulation strategies well suited for aging rural adults following a first cardiac event in tandem with usual cardiac rehabilitation. The intervention helps patients recognize their emotions, balance emotional and physical wellbeing, and implement emotion regulation strategies effectively. Intervention provided in addition to usual cardiac rehabilitation.

Behavioral: eMotion

Healthy living active control

ACTIVE COMPARATOR

Healthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation.

Behavioral: Healthy Living Active Control

Usual care

NO INTERVENTION

Usual cardiac rehabilitation with no additional intervention.

Interventions

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.

eMotion

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.

Healthy living active control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• does not speak English;
• major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
• terminal cancer; and
• legally blind

Sponsors & Collaborators

• Indiana University: lead
• Sigma Theta Tau International Honor Society of Nursing: collaborator
• Jonas Philanthropies: collaborator

Study Sites (4)

Indiana University Health West Hospital

Avon, Indiana, 46123, United States

Location

Indiana University Health Bedford Hospital

Bedford, Indiana, 47421, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Tipton Hospital

Tipton, Indiana, 46072, United States

Location

Related Publications (1)

• Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.

  PMID: 34741536 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Kelly L Wierenga, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Nursing

Model Details: 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 22, 2020
• Study Start: January 12, 2021
• Primary Completion: May 1, 2023
• Study Completion: October 10, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

US (4)