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| Name | Class |
|---|---|
| OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark | UNKNOWN |
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This study evaluates the effectiveness and cost-effectiveness of a therapy-assisted internet-based intervention in patients with ischemic heart disease and co-morbid depression and anxiety referred for cardiac rehabilitation. Half of the patients will receive the intervention and the other half usual care. We hypothesize that the intervention will lead to a reduction in patients' symptoms of depression and anxiety and be cost-effective.
The 12-week intervention will consist of 9 modules and 2 optional modules that will be delivered to patients in the active intervention via a platform or app. Psychologists will provide asynchronous guidance via the platform. Motivational interviewing will be used during the intervention to prevent dropout. The psychologist may contact patients via telephone during the intervention if needed. All patients will have access to the intervention up to 6 months' post intervention so that they can revisit the material and reuse it on a need-to-basis. Patients will be recommended to use this option and to note specific time points in their agenda where they will access the intervention. A brief purpose-designed interview protocol that includes elements from the SCAN interview will be carried out by psychologists trained in conducting the interview.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment for depression and anxiety | Experimental | Treatment |
|
| Usual care | Other | Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth intervention | Other | Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of depression | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of anxiety | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 3 months |
| Symptoms of depression | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne S Pedersen, PhD | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | ||||
| Helle Lynge Kanstrup |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413109 | Derived | Pedersen SS, Andersen CM, Ahm R, Skovbakke SJ, Kok R, Helmark C, Wiil UK, Schmidt T, Olsen KR, Hjelmborg J, Zwisler AD, Frostholm L. Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol. BMC Cardiovasc Disord. 2021 Jan 7;21(1):20. doi: 10.1186/s12872-020-01801-w. |
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Comparison of depression/anxiety treatment versus usual care
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| Usual Care | Other | Treatment according to national clinical guideline (referral to GP) |
|
| 6 months |
| Symptoms of anxiety | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 6 months |
| Symptoms of depression | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 12 months |
| Symptoms of anxiety | Measured by Hospital Anxiety and Depression Scale (range 0-21 - high score = more symptoms) | 12 months |
| Patient-reported quality of life | Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL) | 3 months |
| Patient-reported quality of life | Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL) | 6 months |
| Patient-reported Quality of life | Measured by the Health-related quality of life questionnaire (HeartQoL) - The measure consists of a global, physical and emotional sub scale. Score range is from 0-3 (high score = better QoL) | 12 months |
| Dropout | Number of patients dropped out in each arm | 3 months |
| Cost-effectiveness | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level | 3 months |
| Cost-effectiveness | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level | 6 months |
| Cost-effectiveness | EUROQOL - 5 Questions with 5 levels with level 5 being the worst level | 12 months |
| Perceived Stress | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) | 3 months |
| Perceived Stress | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) | 6 months |
| Perceived Stress | Measured with the Perceived Stress Scale (range 0-40 - high score = highest level of stress) | 12 months |
| Health complaints | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) | 3 months |
| Health complaints | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) | 6 months |
| Health complaints | Measured with the Health Complaints Scale (range 0-95 - 95=worse health) | 12 months |
| Aarhus |
| Denmark |
| Herlev / Gentofte Hospital | Herlev | Denmark |
| Regionshospital Nordjylland | Hjørring | Denmark |
| Holbæk Hospital | Holbæk | Denmark |
| Holbæk Sygehus | Holbæk | Denmark |
| Sygehus Lillebælt Kolding | Kolding | Denmark |
| Odense University Hospital (Odense) | Odense | Denmark |
| Randers Municipality | Randers | Denmark |
| Zealand University Hospital | Roskilde | Denmark |
| Odense University Hospital (Svendborg) | Svendborg | Denmark |
| Sygehus Lillebælt | Vejle | Denmark |
| Vordingborg Municipality | Vordingborg | Denmark |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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