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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Depression, Anxiety

Treatments: Other: eHealth intervention; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT04172974

18/39431

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups

Treatment for depression and anxiety

Experimental group

Description:

Treatment

Treatment:

Other: eHealth intervention

Usual care

Other group

Description:

Usual Care

Treatment:

Other: Usual Care