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

Not Applicable

Completed

• Conditions: Depression, Anxiety
• Interventions: Other: eHealth intervention; Other: Usual Care

• Registration Number: NCT04172974
• Lead Sponsor: University of Southern Denmark

Brief 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.

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 Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-05-22
• Primary Completion: 2023-12-09
• Study Completion: 2024-09-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment for depression and anxiety	eHealth intervention	Treatment
Usual care	Usual Care	Usual Care

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Symptoms of depression	12 months	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Patient-reported Quality of life	12 months	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)
Symptoms of anxiety	12 months	Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms)
Patient-reported quality of life	6 months	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)
Dropout	3 months	Number of patients dropped out in each arm
Health complaints	12 months	Measured with the Health Complaints Scale (range 0-95 - 95=worse health)
Cost-effectiveness	12 months	EUROQOL - 5 Questions with 5 levels with level 5 being the worst level
Perceived Stress	12 months	Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress)

Trial Locations

Locations (13)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Holbæk Hospital; 🇩🇰 Holbæk, Denmark

Randers Municipality; 🇩🇰 Randers, Denmark

Odense University Hospital (Svendborg); 🇩🇰 Svendborg, Denmark

Helle Lynge Kanstrup; 🇩🇰 Aarhus, Denmark

Regionshospital Nordjylland; 🇩🇰 Hjørring, Denmark

Herlev / Gentofte Hospital; 🇩🇰 Herlev, Denmark

Holbæk Sygehus; 🇩🇰 Holbæk, Denmark

Odense University Hospital (Odense); 🇩🇰 Odense, Denmark

Sygehus Lillebælt Kolding; 🇩🇰 Kolding, Denmark

Zealand University Hospital; 🇩🇰 Roskilde, Denmark

Sygehus Lillebælt; 🇩🇰 Vejle, Denmark

Vordingborg Municipality; 🇩🇰 Vordingborg, Denmark