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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
239
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.
Ängelholms sjukhus
Ängelholm, Sweden
Enköpings lassarett
Enköping, Sweden
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)
Time frame: 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
Time frame: At baseline and 3 months later (after intervention)
Change in Quality of Life (difference between the intervention and the control group)
Ratings on EQ5d and Ladder of Life (LL)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, after (3 months after baseline) and 7 months after treatment
Change in Cardiac Anxiety (difference between the intervention and the control group)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Falu Lasarett
Falun, Sweden
Gävle sjukhus
Gävle, Sweden
Sahlgrenska sjukhuset
Gothenburg, Sweden
Hässleholms sjukhus
Hässleholm, Sweden
Blekinge sjukhus
Karlskrona, Sweden
Karlstad sjukhus
Karlstad, Sweden
Kungälvs sjukhus
Kungälv, Sweden
Skaraborgs sjukhus
Lidköping, Sweden
...and 15 more locations
Cardiac Anxiety Questionnaire (CAQ)-ratings
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline, after (3 months after baseline) and 7 months after treatment
Quality of the Intervention
Behavioral Activation for Depression Scale (BADS)-ratings
Time frame: 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
Time frame: 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)
Time frame: At baseline, after (3 months after baseline) and 7 months after treatment