Internet-based Intervention in Cardioverter-defibrillator Patients to Enhance Quality of Life

Study Overview
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Brief Summary
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The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet. The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.

Official Title
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WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial

Conditions
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Heart Diseases, Implantable Cardioverter-Defibrillators

Intervention / Treatment
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* Behavioral: web-based multifactorial intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients implanted with a cardioverter-defibrillator (ICD) between 18-75 years of age speaking and understanding Dutch with access to the internet and ability to use the internet providing written informed consent Exclusion Criteria: a life expectancy less than 1 year a history of psychiatric illness other than affective/anxiety disorders on the waiting list for heart transplantation with insufficient knowledge of the Dutch language

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based behavioral intervention<br> | Behavioral: web-based multifactorial intervention<br>* 12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy<br>* Other names: Relaxation therapy;|
| No Intervention: Usual care<br> | Behavioral: web-based multifactorial intervention<br>* 12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy<br>* Other names: Relaxation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety |  | Baseline | 
| Anxiety |  | 14 weeks | 
| Anxiet |  | 26 weeks | 
| Anxiety |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol awakening response |  | Baseline | 
| Cortisol awakening response |  | 14 weeks | 
| Cortisol awakening response |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, ICD concerns, Quality of life