Internet-based Cognitive Behavior Therapy After Myocardial Infarction (U-CARE: Heart)

Uppsala University

Status: Completed

Conditions: Myocardial Infarction; Depression; Anxiety

Treatments: Behavioral: Internet-based CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01504191

U-CARE: Heart

Details and patient eligibility

About

The overall aim and primary objective is to evaluate the effects on level of depression and anxiety of an Internet-based CBT-program in depressed and/or anxious patients after a myocardial infarction (MI).

Full description

Major or minor depressive disorders and anxiety disorders are present in many patients with cardiovascular disease (CVD) and are associated with adverse cardiovascular outcomes, even after controlling for other risk factors. 500 patients with symptoms of anxiety and/or depression after MI will be randomized either to a 14 week Internet-based CBT-program or to treatment as usual (TAU) which is the control condition. A reference group of 250 participants without depressive or anxiety symptoms will also be studied during TAU. Data will be collected before, after and 7 months after treatment. Anxiety and depression according to ratings on the Hospital Anxiety and Depression Scale (HADS) are the primary outcome measures.

Enrollment: 239 patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients younger than 75 years with a recent acute MI (< 3 months)
• Depression and/or anxiety score of > 7 on one or both of the HADS subscales (concerns only the intervention, not the reference group)

Exclusion criteria

• Patients that are scheduled for a coronary artery bypass surgery (CABG)
• Unable or unwilling to use computer or Internet
• Difficulties in reading or understanding Swedish
• A life expectancy of less than a year
• Anticipated poor compliance (multi-disease, substance abuse etc.)
• Highly depressed or suicidal (MADRS-score > 29 or MADRS item 9 > 3)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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239 participants in 2 patient groups

Internet-based CBT

Experimental group

Description:

Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program.

Treatment:

Behavioral: Internet-based CBT

Treatment as usual (TAU)

No Intervention group

Description:

Control: After randomization patients with symptoms of anxiety and/or depression after MI will participate in the treatment as usual (TAU). Reference: A reference group without depressive or anxiety symptoms will participate in the treatment as usual (TAU).