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

Psychotherapeutic web-based intervention for anxious patients after receiving shocks by an implantable cardioverter defibrillator: a randomized wait-list controlled pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14739101
Enrollment
24
Registered
2015-06-15
Start date
2015-06-16
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The intervention consists of three single and seven group psychotherapeutic sessions through a web-based video conference software. For this purpose we created a therapeutic manual including psychoedu

Sponsors

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

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactSascha Wohnsland
Sascha.Wohnsland@med.uni-heidelberg.de004962215637357

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026