Web-based psychotherapeutic intervention to reduce anxiety levels in patients with an implantable cardioverter defibrillator and co-morbid anxiety after shocks

Completed

Conditions: ICD patients receiving shocks with co-morbid anxiety disorder
Mental and Behavioural Disorders

Registration Number: ISRCTN14739101

Lead Sponsor: Department of Internal Medicine II (General Internal and Psychosomatic Medicine)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 24

Inclusion Criteria

1. ICD patients receiving one or multiple shocks
2. Confirmed diagnosis of an anxiety disorder (SCID interview)
3. Sufficient anxiety level : HADS = 8 or GAD-7 = 10 or panic disorder in PHQ-D
4. Age between 18 and 75 years
5. Sufficient knowledge of the German language
6. Written informed consent

Exclusion Criteria

1. Severe dementia or any other psychiatric or cognitive diseases which hampers the capacity to consent
2. Any acute or chronic disease which prevents patients to participate in the intervention
3. No internet accessible

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Patients’ satisfaction with the intervention on a visual analogue scale directly after treatment <br>2. The preliminary effect size for change in anxiety level measured by GAD-7 <br>3. Recruitment rate is determined by measuring the percentage of all ICD patients willing to participate in the intervention to all meeting the inclusion criteria

Secondary Outcome Measures

Name	Time	Method
1. Drop out rates <br>2. Anxious, depressive and traumatic symptoms and quality of life of ICD patients and their partners or care givers are measured with HADS, PHQ-D, SF-36, GHQ-12 and IES-R before (T0) and after intervention (T1) and at 6 and 12 month follow-up (T2, T3)<br>3. Number of cardiological treatments in inpatient and outpatient settings and the frequency of ICD shocks at T0, T1, T2 and T3<br>