Cardiac EventeMotionNCT04441086
Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
A study testing eMotion in people with Cardiac Event and Emotions, run by Indiana University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Event, Emotions
- What is being tested?
- eMotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Jan 2021to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- does not speak English;
- major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
- terminal cancer; and
- legally blind
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Health West Hospital
Avon, Indiana, 46123
Indiana University Health Bedford Hospital
Bedford, Indiana, 47421
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Indiana University Health Tipton Hospital
Tipton, Indiana, 46072
About this study
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.
Read the 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.
- Conditions
- Cardiac Event, Emotions
- Being tested
- eMotion, Healthy Living Active Control
- Keywords
- Emotion regulation
- Medical subject headings
- Cardiovascular Diseases, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMotionBehavioural
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 ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Healthy Living Active Control |
| Usual care | No intervention | Usual cardiac rehabilitation with no additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Moderate to Vigorous Physical Activity (MVPA)
Minutes spent in MVPA
Measured: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks
Secondary outcomes (5)
Change in Depression Symptoms
Symptoms of depression measured using the Depression, Anxiety, and Stress Scale (DASS)
Measured: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Anxiety Symptoms
Symptoms of anxiety measured using the Depression, Anxiety, and Stress Scale (DASS)
Measured: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Pain Symptoms
Pain will be measured with the Brief Pain Inventory
Measured: Baseline to 12 weeks, 20 weeks, and 52 weeks
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
Measured: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Fatigue Symptoms
Fatigue will be measured using the Fatigue Severity Scale
Measured: Baseline to 12 weeks, 20 weeks, and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start12 Jan 2021
- Primary completion1 May 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing, Jonas Philanthropies
- Responsible party
- Principal investigator, Kelly L. Wierenga, Indiana University
- Investigators
- Kelly L Wierenga, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441086
- Sponsor's protocol ID
- 2002325890
- Acronym
- eMotion
- Status last verified
- Oct 2023
- First submitted
- 11 Jun 2020
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34741536
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Intervention to Sustain Physical Activity in Rural-dwelling Women and Men After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04441086
- Acronym / sponsor ID
- eMotion / 2002325890
- Conditions
- Cardiac Event, Emotions
- Keywords
- Emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Sigma Theta Tau International Honor Society of Nursing, Jonas Philanthropies
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 group randomized control trial. Conditions include eMotion intervention, healthy living active control, and usual care.
| Arm | Type | Receives |
|---|---|---|
| eMotion | Experimental | Behavioral: eMotionThe 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. |
| Healthy living active control | Active comparator | Behavioral: Healthy Living Active ControlHealthy living strategies based on American Heart Association education. Intervention provided in addition to usual cardiac rehabilitation. |
| Usual care | No intervention | –Usual cardiac rehabilitation with no additional intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- does not speak English;
- major Axis 1 psychiatric diagnosis (e.g. schizophrenia);
- terminal cancer; and
- legally blind
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eMotionContent 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. | Behavioural | eMotion |
| Healthy Living Active ControlThe 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. | Behavioural | Healthy living active control |
Primary outcome
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
5 secondary outcomes
Change in Depression Symptoms
Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Anxiety Symptoms
Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Pain Symptoms
Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Sleep efficiency
Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
Change in Fatigue Symptoms
Time frame: Baseline to 12 weeks, 20 weeks, and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Derived from this study: PubMed 34741536Dibben 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.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly L Wierenga, PhD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eMotion in people with Cardiac Event and Emotions, run by Indiana University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Moderate to Vigorous Physical Activity (MVPA) (time frame: 1 week trials at baseline, 12 weeks, 20 weeks, and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04441086, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.