Depression, Anxiety, Myocardial Infarction
Conditions
Keywords
myocardial infarction, depression, anxiety, Internet-based CBT, genetic disposition
Brief summary
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
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.
Interventions
BEHAVIORALInternet-based CBT
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.
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression (difference between the intervention and the control group) | At baseline and 3 months later (after intervention) | Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS) |
| Change in Anxiety (difference between the intervention and the control group) | At baseline and 3 months later (after intervention) | Hospital Anxiety and Depression Scale (HADS) - anxiety ratings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress behaviors (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Everyday Life Stress Scale (ELSS)-ratings |
| Change in Fatigue (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Maastricht Questionnaire (MQ)-ratings |
| Change in Cardiac Anxiety (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Cardiac Anxiety Questionnaire (CAQ)-ratings |
| Change in Sleeping Problems (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Insomnia Severity Index (ISI)-ratings |
| Change in Quality of Life (difference between the intervention and the control group) | At baseline, during, after (3 months after baseline) and 7 months after treatment | Ratings on EQ5d and Ladder of Life (LL) |
| Change in Posttraumatic Growth (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | The Posttraumatic Growth Inventory - Short Form (PTGI-SF)-ratings |
| Quality of the Intervention | At baseline, after (3 months after baseline) and 7 months after treatment | Behavioral Activation for Depression Scale (BADS)-ratings |
| Change to Follow-up in Anxiety (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Hospital Anxiety and Depression Scale (HADS) - anxiety ratings |
| Change to Follow-up in Depression (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS) |
| Change in Posttraumatic Stress (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | Posttraumatic Stress Disorder Checklist- Civilian Version (PCL-C)-ratings |
| Change in Perceived Social Support (difference between the intervention and the control group) | At baseline, after (3 months after baseline) and 7 months after treatment | ENRICHED Social Support Inventory (ESSI)-ratings |
Countries
Sweden
Outcome results
None listed