NCT05128981

Brief Summary

Myocardial infarction (MI) is one of the leading cause s of health loss globally, representing a large proportion of general disability. Anxiety and depression occur in 20-30 percent of patients following MI and have been identified as risk factors for recurrent adverse cardiac event. The purpose of our this study is to develop and evaluate a disease specific cognitive behavioral therapy (C BT) protocol to reduce cardia anxiety, depression, increase physical inactivity and quality of life (Q oL) in patients following MI

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

November 10, 2021

Last Update Submit

January 9, 2023

Conditions

Myocardial InfarctionCardiac AnxietyCBTExposure

Outcome Measures

Primary Outcomes (3)

  • 12-Item Short-Form Health Survey (SF-12)

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

    Baseline

  • 12-Item Short-Form Health Survey (SF-12)

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

    2 months from baseline

  • 12-Item Short-Form Health Survey (SF-12)

    General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life. General quality of life, with a score ranging from 0 to 100. A higher score indicating a better quality of life.

    8 months from baseline

Secondary Outcomes (34)

  • Cardiac anxiety questionnaire

    Baseline

  • Cardiac anxiety questionnaire

    2 months from baseline

  • Cardiac anxiety questionnaire

    8 months from baseline

  • Body Sensation Questionnaire

    Baseline

  • Body Sensation Questionnaire

    2 months from baseline

  • +29 more secondary outcomes

Study Arms (1)

MI-CBT via the Internet

OTHER

The MI-specific CBT will consist of 8 modules delivered via the Internet with home assignments that can be reviewed and reported in the research groups secure platform.

Behavioral: MI-CBT

Interventions

MI-CBTBEHAVIORAL

Education of MI and common reactions, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention

MI-CBT via the Internet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ( - )MI ≥ 6 months before assessment ( - )Age 18-75 years endorsed cardiac anxiety that leads to significant distress or interferes with daily life (Cardiac Anxiety Questionnaire (CAQ); score ≥20) ( - ) On optimal medical treatment ( - )Able to read and write in Swedish.

You may not qualify if:

  • ( - ) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%) ( - ) significant valvular disease ( - ) planned coronary artery bypass surgery or other invasive therapy ( - ) other severe medical illness ( - )any medical restriction to physical exercise ( - )severe psychiatric disorder, severe depression, or risk of suicide ( - )alcohol dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 22, 2021

Study Start

October 28, 2021

Primary Completion

December 10, 2022

Study Completion

December 10, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)