eHealth Intervention to Manage Depression and Anxiety in Patients With Ischemic Heart Disease

Depression, Anxiety Clinical Trial

— eMYHeart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172974
• Other study ID #: 18/39431
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University of Southern Denmark
• Contact: Susanne S Pedersen, PhD
• Phone: +4565507992
• Email: sspedersen[@]health.sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Coronary Artery Disease
• Depression
• Depression, Anxiety
• Depressive Disorder
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	Odense Patient Data Explorative Network

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of depression	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	3 months
Secondary	Symptoms of anxiety	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	3 months
Secondary	Symptoms of depression	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	6 months
Secondary	Symptoms of anxiety	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	6 months
Secondary	Symptoms of depression	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	12 months
Secondary	Symptoms of anxiety	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Dropout	Number of patients dropped out in each arm	3 months
Secondary	Cost-effectiveness	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level	3 months
Secondary	Cost-effectiveness	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level	6 months
Secondary	Cost-effectiveness	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level	12 months
Secondary	Perceived Stress	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)	3 months
Secondary	Perceived Stress	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)	6 months
Secondary	Perceived Stress	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)	12 months
Secondary	Health complaints	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)	3 months
Secondary	Health complaints	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)	6 months
Secondary	Health complaints	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)	12 months