A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Uppsala University
- Enrollment
- 239
- Locations
- 25
- Primary Endpoint
- Change in Anxiety (difference between the intervention and the control group)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Louise-von Essen
Programme Director for U-CARE
Uppsala University
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Change in Anxiety (difference between the intervention and the control group)
Time Frame: At baseline and 3 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
Change in Depression (difference between the intervention and the control group)
Time Frame: At baseline and 3 months later (after intervention)
Hospital Anxiety and Depression Scale (HADS) - depression ratings; Montgomery Åsberg Depression Rating Scale (MADRS)
Secondary Outcomes
- 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)
- 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)
- Change in Stress behaviors (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Fatigue (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Sleeping Problems (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Cardiac Anxiety (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Posttraumatic Stress (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Change in Posttraumatic Growth (difference between the intervention and the control group)(At baseline, after (3 months after baseline) and 7 months after treatment)
- Quality of the Intervention(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)(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)(At baseline, after (3 months after baseline) and 7 months after treatment)