ICD patients receiving shocks with co-morbid anxiety disorder Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patients’ satisfaction with the intervention on a visual analogue scale directly after treatment 2. The preliminary effect size for change in anxiety level measured by GAD-7 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
| Measure | Time frame |
|---|---|
| 1. Drop out rates 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) 3. Number of cardiological treatments in inpatient and outpatient settings and the frequency of ICD shocks at T0, T1, T2 and T3 | — |
Countries
Germany