Anxiety, Depression, Quality of Life
Conditions
Keywords
Implantable Cardioverter Defibrillators, Heart Failure, Anxiety, Depression, Quality of Life, Remote Care, Prevention
Brief summary
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.
Detailed description
See Summary.
Interventions
BEHAVIORALICD-Forum
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: 1. Introduction to participants and online system 2. Knowledge regarding ICDs 3. Strategies for behavior change 4. Psychological models for anxiety and depression 5. Strategies to cope with avoidance, anxiety and depression 6. Resume, evaluation, resolution of open questions, goal setting, good bye
Sponsors
University of Wuerzburg
Campus Bad Neustadt
Hospital Rothenburg ob der Tauber
University Hospital Brandenburg
Klinikum Aschaffenburg-Alzenau
Klinikum Bad Woerishofen
University of Leipzig
Wuerzburg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | assessment tools for aspects of psychosocial well-being (German versions will be used): Anxiety: Cardiac Fear Questionnaire (Hoyer & Eifert, 2001); Depression: Hospital Anxiety and Depression Scale (Hinz & Brähler, 2011); QoL: MOS 36-item short-form health survey (Ware & Sherbourne, 1992) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 1. assessed by NYHA-class, LVEF, blood pressure 2. measured through IES, Maercker, & Schützwohl, 1998 and PDEQ, Fuglsang, Moergeli, et al., 2002 and FSAS, Kuhl, et al., 2006 3. measured through smoking, BMI 4. measured through FPAS, Burns, et.al., 2005 and ICD-Safety and Concerns Scales, Crössmann, 2005 5. measured through SCL-9-K, Klaghofer & Brähler, 2001 6. measured through DS14, Grande, et al., 2004 7. measured through BSSS, Schulze, & Schwarzer, 2003 8. measured according to Schweikert, Hahmann & Leidl, 2008 |
| psychophysiological parameters: heart rate variability | up to 1 week before ICD-implantation (T0) and 1, 3, 6, and 12 months after ICD-implantation | time- and frequency domain parameters of HRV (Camm et al., 1996) |
| biometric markers: 1. proinflammatory cytokines 2. coagulation parameters | up to 1 week before ICD-implantation (T0) and 6 months after ICD-implantation | 1. ELISA analysis of IL-1β, IL-6, TNF-α 2. Fibrinogen |
Countries
Germany
Outcome results
None listed