EHealth Intervention to Manage Depression and Anxiety in Patients with Ischemic Heart Disease (eMindYourHeart)

Screening and Managing Depression and Anxiety with Therapist-assisted EHealth Intervention in Patients with Ischemic Heart Disease in the Cardiac Rehabilitation Setting

This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.

Study Overview

• Status: Completed
• Conditions: Depression, Anxiety
• Intervention / Treatment: Other: eHealth intervention; Other: Usual Care

Detailed Description

The 12-week intervention will consist of 9 modules and 2 optional modules that will be delivered to patients in the active intervention via a platform or app. Psychologists will provide asynchronous guidance via the platform. Motivational interviewing will be used during the intervention to prevent dropout. The psychologist may contact patients via telephone during the intervention if needed. All patients will have access to the intervention up to 6 months' post intervention so that they can revisit the material and reuse it on a need-to-basis. Patients will be recommended to use this option and to note specific time points in their agenda where they will access the intervention. A brief purpose-designed interview protocol that includes elements from the SCAN interview will be carried out by psychologists trained in conducting the interview.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Aarhus, Denmark
    • Helle Lynge Kanstrup
  • Herlev, Denmark
    • Herlev / Gentofte Hospital
  • Hjørring, Denmark
    • Regionshospital Nordjylland
  • Holbæk, Denmark
    • Holbæk Hospital
  • Holbæk, Denmark
    • Holbæk Sygehus
  • Kolding, Denmark
    • Sygehus Lillebælt Kolding
  • Odense, Denmark
    • Odense University Hospital (Odense)
  • Randers, Denmark
    • Randers Municipality
  • Roskilde, Denmark
    • Zealand University Hospital
  • Svendborg, Denmark
    • Odense University Hospital (Svendborg)
  • Vejle, Denmark
    • Sygehus Lillebælt
  • Vordingborg, Denmark
    • Vordingborg municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Diagnosis of ischemic heart disease (diagnostic codes I20-I25)
• Referred for CR
• HADS score ≥ 8 on depression and or anxiety
• Access to a computer or smart phone
• Ability to use computer or smart phone
• Proficient in the Danish language
• Signing an informed consent form

Exclusion Criteria:

• Severe psychiatric disorder (i.e., borderline disorder, schizophrenia or bipolar disorder)
• Severe cognitive difficulties (e.g. severe brain damage, mental retardation, or dementia) that will prevent patients from participating
• Endorsement of suicidal ideation with daily suicidal thoughts (PHQ-9 item 9 >2)
• Participation in other intervention studies (unless they are clinical studies)
• Seeing a psychologist or mental health professional for the treatment of anxiety and depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment for depression and anxiety; Treatment	Other: eHealth intervention; Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
Other: Usual care; Usual Care	Other: Usual Care; Treatment according to national clinical guideline (referral to GP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of depression	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of anxiety	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	3 months
Symptoms of depression	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	6 months
Symptoms of anxiety	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	6 months
Symptoms of depression	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	12 months
Symptoms of anxiety	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	12 months
Patient-reported quality of life	Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL)	3 months
Patient-reported quality of life	Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL)	6 months
Patient-reported Quality of life	Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL)	12 months
Dropout	Number of patients dropped out in each arm	3 months
Cost-effectiveness	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level	3 months
Cost-effectiveness	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level	6 months
Cost-effectiveness	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level	12 months
Perceived Stress	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)	3 months
Perceived Stress	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)	6 months
Perceived Stress	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)	12 months
Health complaints	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)	3 months
Health complaints	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)	6 months
Health complaints	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)	12 months

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark
• Investigators: Principal Investigator: Susanne S Pedersen, PhD, University of Southern Denmark

Publications and helpful links

General Publications

• Pedersen SS, Andersen CM, Ahm R, Skovbakke SJ, Kok R, Helmark C, Wiil UK, Schmidt T, Olsen KR, Hjelmborg J, Zwisler AD, Frostholm L. Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol. BMC Cardiovasc Disord. 2021 Jan 7;21(1):20. doi: 10.1186/s12872-020-01801-w.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Actual): December 9, 2023
• Study Completion (Actual): September 11, 2024

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Mood Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Anxiety Disorders; Depression; Depressive Disorder; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 18/39431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No