This trial is active, not recruiting.

Conditions anxiety, depression, quality of life
Treatment icd-forum
Sponsor Paul Pauli
Collaborator University of Wuerzburg
Start date May 2012
End date November 2015
Trial size 119 participants
Trial identifier NCT01589913, UKW-CHFC-G2


Aim and Background: Although implantable cardioverter defibrillators (ICD) save lives, many ICD-patients experience psychosocial complications such as anxiety disorders, depression and reduced quality of life after ICD-implantation. A recent review has indicated great potential for psychosocial interventions to reduce anxiety and to increase exercise capacity of ICD-patients. In a previous study, the investigators showed that mailed information about technical, medical and psychological effects of ICD plus phone counseling are effective interventions for reducing anxiety, psychological distress and increasing QoL in ICD-patients < 65 years. In a pilot study the investigators also documented promising effects of an internet based intervention with similar content.

Method: In a prospective, multicenter, multidisciplinary, half-open, part-randomized, controlled clinical trial N = 200 patients with an ICD will either receive medical care as usual or additionally attend a psychosocial prevention program via remote care. Psychosocial support will be provided utilizing the advantages of the internet. Thus, patient-centered support will be offered independent from time and location.

Outcome measures are psychometric data (questionnaires on cardiac fear, etc.), cardiac functioning, and clinical status which will be assessed up to 1 week before ICD-implantation (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12 months after T0 (T3). Furthermore, demographic data, personality characteristics, expectations, physiology, pro-inflammatory cytokines and cardiac status will be assessed as mediating or moderating variables.

Hypotheses: A web-based psychosocial intervention in addition to medical care as usual leads to increased QoL and reduced anxiety and depression. Secondary goals are the identification of psychosocial and medical predictors, mediators, and moderators of treatment efficacy. Moreover, differences between patients with ICDs implanted for primary vs. secondary prevention will be explored.

Conclusion: This project will evaluate the feasibility and efficacy of an internet based intervention for ICD-patients. Furthermore, the investigators aim at identifying predictors and mediators of treatment outcome. This will improve interdisciplinary care for ICD-patients; further applications for other cardiovascular disorders as well as preventive programs for heart failure seem possible.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
icd-forum www.icd-forum.de
The CBT based internet program ICD-Forum is designed to increase QoL, and decrease anxiety and depression in ICD-patients. The program includes a therapist moderated asynchronous discussion group and content focused modules following a six weeks schedule: Introduction to participants and online system Knowledge regarding ICDs Strategies for behavior change Psychological models for anxiety and depression Strategies to cope with avoidance, anxiety and depression Resume, evaluation, resolution of open questions, goal setting, good bye
(No Intervention)
Standard information provided by hospitals on ICD-technology as well as consequences of ICD-implantation plus medical aftercare including cardiology appointments at 1, 3, and 6 months, and one year after ICD-implantation.

Primary Outcomes

change of psychosocial well-being (combined score for measures of anxiety, depression, and quality of life) from week 1 (T1) to one week after (T2) the 6-weeks prevention program
time frame: up to 1 week before ICD-implantation (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12 months after T0 (T3)

Secondary Outcomes

1. Health status 2. ICD-related trauma 3. Life-style factors 4. ICD-Related concerns 5. Psychological well-being 6. Type-D personality 7. Social support 8. Economic efficiency
time frame: up to 1 week before ICD-implantation (T0), in week 1 (T1) and within one week after (T2) the 6-weeks prevention program, and 12 months after T0 (T3)
psychophysiological parameters: heart rate variability
time frame: up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation
biometric markers: 1. proinflammatory cytokines 2. coagulation parameters
time frame: up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Implanted ICD - Internet access can be installed during completion of the prevention program Exclusion Criteria: - Medical reasons preventing participation of the prevention program (e.g. emergency hospitalization) for more than one week of the program - Suicidality (Patients with scores > 8 on the depression subscale of the HADS will be assessed via interviews conducted by a qualified psychologist) - Severe cognitive impairment (< 17 points in the MMST; Kessler, J., Markowitsch, H. J. & Denzler, P. (2000). Mini-Mental-Status-Test (MMST). Göttingen: Beltz Test GMBH. [Deutsche Adaption]) - Insufficient command of German to follow the intervention program - Current ICD-10 diagnosis: - F1x: Mental and behavioral disorders due to psychoactive substance use - F2x: Schizophrenia, schizotypal and delusional disorders - F30: Manic Episode - F31: Bipolar affective disorder

Additional Information

Official title Remote Care for Reducing Cardiac Fear, Fear of Dying, Depression, and Increasing Quality of Life in ICD‐Patients With Cardiac Insufficiency/at Risk for Fatal Cardiac Arrhythmia.
Principal investigator Paul Pauli, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Wuerzburg University Hospital.