Internet-based Cognitive Behavior Therapy After Myocardial Infarction

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction

Conditions
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Depression, Anxiety, Myocardial Infarction

Intervention / Treatment
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* Behavioral: Internet-based CBT


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based CBT<br>Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program. | Behavioral: Internet-based CBT<br>* The participants read texts and do weekly homework assignments instructed from an Internet page. Additional resources like discussion forum, pictures, animations, videos and sounds will be a part of the treatment program. A psychologist will communicate with the participants through internal text-messages. The therapist will devote about 10 minutes to each participant each week via the Internet. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment etc.<br>|
| No Intervention: Treatment as usual (TAU)<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression (difference between the intervention and the control group) | Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS) | At baseline and 3 months later (after intervention) | 
| Change in Anxiety (difference between the intervention and the control group) | Hospital Anxiety and Depression Scale (HADS) - anxiety ratings | At baseline and 3 months later (after intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life (difference between the intervention and the control group) | Ratings on EQ5d and Ladder of Life (LL) | At baseline, during, after (3 months after baseline) and 7 months after treatment | 
| Change in Perceived Social Support (difference between the intervention and the control group) | ENRICHED Social Support Inventory (ESSI)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change in Stress behaviors (difference between the intervention and the control group) | Everyday Life Stress Scale (ELSS)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change in Fatigue (difference between the intervention and the control group) | Maastricht Questionnaire (MQ)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change in Cardiac Anxiety (difference between the intervention and the control group) | Cardiac Anxiety Questionnaire (CAQ)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change in Sleeping Problems (difference between the intervention and the control group) | Insomnia Severity Index (ISI)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change in Posttraumatic Stress (difference between the intervention and the control group) | Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change in Posttraumatic Growth (difference between the intervention and the control group) | The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Quality of the Intervention | Behavioral Activation for Depression Scale (BADS)-ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change to Follow-up in Anxiety (difference between the intervention and the control group) | Hospital Anxiety and Depression Scale (HADS) - anxiety ratings | At baseline, after (3 months after baseline) and 7 months after treatment | 
| Change to Follow-up in Depression (difference between the intervention and the control group) | Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS) | At baseline, after (3 months after baseline) and 7 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial infarction, depression, anxiety, Internet-based CBT, genetic disposition