Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-based CBT | Experimental | Randomized patients with symptoms of anxiety and/or depression after MI will participate in an Internet-based CBT-program. |
|
| Treatment as usual (TAU) | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based CBT | Behavioral | 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. |
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louise von Essen, PhD | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ängelholms sjukhus | Ängelholm | Sweden | ||||
| Enköpings lassarett |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36581833 | Derived | Leissner P, Held C, Rondung E, Olsson EMG. The factor structure of the cardiac anxiety questionnaire, and validation in a post-MI population. BMC Med Res Methodol. 2022 Dec 29;22(1):338. doi: 10.1186/s12874-022-01820-5. | |
| 34028358 | Derived | Humphries SM, Wallert J, Norlund F, Wallin E, Burell G, von Essen L, Held C, Olsson EMG. Internet-Based Cognitive Behavioral Therapy for Patients Reporting Symptoms of Anxiety and Depression After Myocardial Infarction: U-CARE Heart Randomized Controlled Trial Twelve-Month Follow-up. J Med Internet Res. 2021 May 24;23(5):e25465. doi: 10.2196/25465. |
| Label | URL |
|---|---|
| U-CARE | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
| Enköping |
| Sweden |
| Falu Lasarett | Falun | 79129 | Sweden |
| Gävle sjukhus | Gävle | 80187 | 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 |
| Ljungby lasarett | Ljungby | Sweden |
| Skånes universitetssjukhus | Malmö | Sweden |
| Mora lassarett | Mora | Sweden |
| Nyköpings sjukhus | Nyköping | Sweden |
| Oskarshamns sjukhus | Oskarshamn | Sweden |
| Universitetssjukhuset Örebro | Örebro | 70185 | Sweden |
| Piteå älvdals sjukhus | Piteå | Sweden |
| Danderyds sjukhus | Stockholm | Sweden |
| Karolinska sjukhuset i Huddinge | Stockholm | Sweden |
| Karolinska sjukhuset i Solna | Stockholm | Sweden |
| Södersjukhuset | Stockholm | Sweden |
| Länssjukhuset Sundsvall-Härnösand | Sundsvall | Sweden |
| Uppsala Akademiska sjukhus | Uppsala | 75185 | Sweden |
| Varberg sjukhus | Varberg | Sweden |
| Växjö centrallasarett | Vaxjo | Sweden |
| 30305255 | Derived | Wallert J, Gustafson E, Held C, Madison G, Norlund F, von Essen L, Olsson EMG. Predicting Adherence to Internet-Delivered Psychotherapy for Symptoms of Depression and Anxiety After Myocardial Infarction: Machine Learning Insights From the U-CARE Heart Randomized Controlled Trial. J Med Internet Res. 2018 Oct 10;20(10):e10754. doi: 10.2196/10754. |
| 29519777 | Derived | Norlund F, Wallin E, Olsson EMG, Wallert J, Burell G, von Essen L, Held C. Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial. J Med Internet Res. 2018 Mar 8;20(3):e88. doi: 10.2196/jmir.9710. |
| 25873137 | Derived | Norlund F, Olsson EM, Burell G, Wallin E, Held C. Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial. Trials. 2015 Apr 11;16:154. doi: 10.1186/s13063-015-0689-y. |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
Not provided
Not provided