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| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| Amphia Hospital | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Canisius-Wilhelmina Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Web-based behavioral intervention | Experimental |
| |
| Usual care | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| web-based multifactorial intervention | Behavioral | 12-week multi-factorial web-based behavioral intervention comprised of psycho-education, cognitive behavioral therapy (CBT) and relaxation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Baseline | |
| Anxiety | 14 weeks | |
| Anxiet | 26 weeks | |
| Anxiety | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol awakening response | Baseline | |
| Cortisol awakening response | 14 weeks | |
| Cortisol awakening response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne S Pedersen, PhD | Contact | 31 13 466 2503 | s.s.pedersen@uvt.nl | |
| Mirela Habibovic, MSc | Contact | 31 13 466 4020 | m.habibovic@uvt.nl |
| Name | Affiliation | Role |
|---|---|---|
| Susanne S Pedersen, PhD | Tilburg University, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canisius-Wilhelmina Hospital | Recruiting | Nijmegen | Gelderland | 6500 GS | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29127812 | Derived | Habibovic M, Broers E, Heumen D, Widdershoven J, Pedersen SS, Denollet J. Optimism as predictor of patient-reported outcomes in patients with an implantable cardioverter defibrillator (data from the WEBCARE study). Gen Hosp Psychiatry. 2018 Jan-Feb;50:90-95. doi: 10.1016/j.genhosppsych.2017.10.005. Epub 2017 Nov 8. | |
| 28192003 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 13, 2016 | |
| Reset | Aug 23, 2016 | |
| Release | Feb 6, 2017 |
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| OTHER |
| Onze Lieve Vrouwe Gasthuis | OTHER |
| Vlietland Ziekenhuis | OTHER |
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|
| 52 weeks |
| Amphia Hospital | Recruiting | Breda | North Brabant | 4800 RL | Netherlands |
|
| Catharina Hospital | Recruiting | Eindhoven | North Brabant | 5602 ZA | Netherlands |
|
| Onze Lieve Vrouwe Gasthuis (OLVG) | Recruiting | Amsterdam | North Holland | 1091 AC | Netherlands |
|
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | 3000 CB | Netherlands |
|
| Vlietland Ziekenhuis | Not yet recruiting | Schiedam | Netherlands |
|
| Habibovic M, Denollet J, Cuijpers P, van der Voort PH, Herrman JP, Bouwels L, Valk SD, Alings M, Theuns DA, Pedersen SS. Web-based distress management for implantable cardioverter defibrillator patients: A randomized controlled trial. Health Psychol. 2017 Apr;36(4):392-401. doi: 10.1037/hea0000451. Epub 2017 Feb 13. |
| 25264974 | Derived | Habibovic M, Denollet J, Cuijpers P, Spek VR, van den Broek KC, Warmerdam L, van der Voort PH, Herrman JP, Bouwels L, Valk SS, Alings M, Theuns DA, Pedersen SS. E-health to manage distress in patients with an implantable cardioverter-defibrillator: primary results of the WEBCARE trial. Psychosom Med. 2014 Oct;76(8):593-602. doi: 10.1097/PSY.0000000000000096. |
| 24583632 | Derived | Habibovic M, Cuijpers P, Alings M, van der Voort P, Theuns D, Bouwels L, Herrman JP, Valk S, Pedersen S. Attrition and adherence in a WEB-Based Distress Management Program for Implantable Cardioverter defibrillator Patients (WEBCARE): randomized controlled trial. J Med Internet Res. 2014 Feb 28;16(2):e52. doi: 10.2196/jmir.2809. |
| 20030843 | Derived | Pedersen SS, Spek V, Theuns DA, Alings M, van der Voort P, Jordaens L, Cuijpers P, Denollet J, van den Broek KC. Rationale and design of WEBCARE: a randomized, controlled, web-based behavioral intervention trial in cardioverter-defibrillator patients to reduce anxiety and device concerns and enhance quality of life. Trials. 2009 Dec 23;10:120. doi: 10.1186/1745-6215-10-120. |
| Reset | Mar 24, 2017 |
| Release | Aug 20, 2025 |
| Reset | Sep 9, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 13, 2016 | Aug 23, 2016 | |||
| Feb 6, 2017 | Mar 24, 2017 | |||
| Aug 20, 2025 | Sep 9, 2025 |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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