Internet-based Cognitive Behavior Therapy After Myocardial Infarction (U-CARE Heart)
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Depression Anxiety Myocardial Infarction |
Behavioral: Internet‐based CBT |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Controlled Study of the Effects of Internet-based Cognitive Behavior Therapy on Depression and Anxiety in Patients With a Previous Myocardial Infarction |
- Change in Depression (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after intervention) ] [ Designated as safety issue: No ]
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) [ Time Frame: At baseline and 3 months later (after intervention) ] [ Designated as safety issue: No ]Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
- Change in Quality of Life (difference between the intervention and the control group) [ Time Frame: At baseline, during, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Ratings on EQ5d and Ladder of Life (LL)
- Change in Perceived Social Support (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]ENRICHED Social Support Inventory (ESSI)-ratings
- Change in Stress behaviors (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Everyday Life Stress Scale (ELSS)-ratings
- Change in Fatigue (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Maastricht Questionnaire (MQ)-ratings
- Change in Cardiac Anxiety (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Cardiac Anxiety Questionnaire (CAQ)-ratings
- Change in Sleeping Problems (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Insomnia Severity Index (ISI)-ratings
- Change in Posttraumatic Stress (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Posttraumatic Stress Disorder Checklist‐ Civilian Version (PCL-C)-ratings
- Change in Posttraumatic Growth (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]The Posttraumatic Growth Inventory ‐ Short Form (PTGI-SF)-ratings
- Quality of the Intervention [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Behavioral Activation for Depression Scale (BADS)-ratings
- Change in Myocardial Necrosis and Function (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]Troponin I, S‐NT‐proBNP, GDF‐15, options for others
- Change in Inflammation (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]CRP, IL‐6, IL‐10, IL‐18, matrix metalloproteinases 9 (MMP‐9), ICAM, VCAM, V Willebrand, options for others
- Change in Renal Function (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]creatinine, cystatine C
- Change in Coagulation and Platelets (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]D‐dimer, P‐Selectin, options for others
- Change in Metabolism and Lipoproteins (difference between the intervention and the control group) [ Time Frame: At baseline and 3 months later (after treatment) ] [ Designated as safety issue: No ]HbA1C, s‐glucose, LDL‐cholesterol, HDL‐cholesterol, apoA1, ApoB, options for others
- Change to Follow-up in Anxiety (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]Hospital Anxiety and Depression Scale (HADS) - anxiety ratings
- Change to Follow-up in Depression (difference between the intervention and the control group) [ Time Frame: At baseline, after (3 months after baseline) and 7 months after treatment ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale (HADS) - depression ratings;
Montgomery Åsberg Depression Rating Scale (MADRS)
| Estimated Enrollment: | 750 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Internet‐based CBT
Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet‐based CBT‐program.
|
Behavioral: Internet‐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. |
|
No Intervention: Treatment as usual (TAU)
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). |
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.
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients younger than 75 years with a recent acute MI (< 3 months)
- Depression and/or anxiety score of > 10 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)
Contacts and Locations| Contact: Erik MG Olsson, PhD | 018-4716663 | erik.olsson@pubcare.uu.se |
| Sweden | |
| Falu Lasarett | |
| Falun, Sweden, 79129 | |
| Gävle sjukhus | |
| Gävle, Sweden, 80187 | |
| Uppsala Akademiska sjukhus | |
| Uppsala, Sweden, 75185 | |
| Universitetssjukhuset Örebro | |
| Örebro, Sweden, 70185 | |
| Principal Investigator: | Louise von Essen, PhD | Uppsala University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Louise-von Essen, Programme Director for U-CARE, Uppsala University |
| ClinicalTrials.gov Identifier: | NCT01504191 History of Changes |
| Other Study ID Numbers: | U-CARE Heart |
| Study First Received: | December 19, 2011 |
| Last Updated: | August 27, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Uppsala University:
|
myocardial infarction depression anxiety Internet‐based CBT genetic disposition |
Additional relevant MeSH terms:
|
Myocardial Infarction Anxiety Disorders Depression Depressive Disorder Infarction Mental Disorders Behavioral Symptoms Mood Disorders |
Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013