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A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

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Abstract

Purpose

Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety.

Methods

The study consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1.

Results

The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD-7 scores, 73.0 % had low probability of anxiety and 2.9 % had high anxiety. Higher anxiety levels were associated with recent (p = 0.017) and total number of shocks (p = 0.002). Any shock was associated with fear about shocks (FSAS, p < 0.001) and reduced patient ICD acceptance (FPAS, p = 0.019). In the pilot trial of CBT, median BAI scores decreased from 24.5 to 11 at 1 year (p = 0.031) in the CBT group and GAD-7 scores from 12.5 to 7 (p = 0.063); no significant changes in anxiety scores were observed in the UC group.

Conclusions

Severe anxiety was present in a small proportion of ICD patients, but higher anxiety was associated with recent and total number of shocks. The small pilot study suggested that a simple program of CBT might lower moderate-high anxiety with lasting effects to 1 year and supports the need for a larger trial to validate these results.

Clinical Trial Registration: ClinicalTrials.gov identifier: NCT00851071.

URL: http://clinicaltrials.gov/ct2/show/NCT00851071?term=anxiety+in+icd+patients+cleveland+clinic&rank=1

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Abbreviations

CBT:

Cognitive behavioral therapy

UC:

Usual care

ICD:

Implantable cardioverter defibrillator

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Funding source

The study was supported by a grant from the Cleveland Clinic Bakken Heart Brain Institute. M. Chung has received support from NIH R01 HL111314 and R01 HL090620.

Relationships with industry

M. Chung: industry-sponsored research with Medtronic, Boston Scientific, St. Jude Medical, Biotronik. S. Sears: consultant to Medtronic; are search grants from Medtronic directed to East Carolina University; speaker honorarium from Medtronic, Boston Scientific, St Jude Medical, Biotronik; founder of QOL Apps, Inc. and inventor of ICD Coach. S. Pedersen consultant for Boston Scientific. All other authors disclose no relationships with industry.

Author information

Authors and Affiliations

  1. Department of Cardiovascular Medicine, Cleveland Clinic, 9500 Euclid Ave., J2-2, Cleveland, OH, 44195, USA

    Melanie Panko, Julie St. John, Elizabeth Ching & Mina K. Chung

  2. Department of Psychiatry and Psychology, Cleveland Clinic, Cleveland, OH, USA

    Scott Bea, Karen A. Broer, Kecia-Ann Blissett & Leopoldo Pozuelo

  3. Department of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA

    Mohammed Qintar & Jason J. George

  4. Department of Psychology, East Carolina University, Greenville, NC, USA

    Samuel F. Sears

  5. Department of Psychology and Cardiovascular Sciences, University of Southern Denmark, Odense, Denmark

    Susanne S. Pedersen

  6. Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands

    Mohammed Qintar, Jason J. George, Melanie Panko, Scott Bea, Karen A. Broer, Julie St. John, Kecia-Ann Blissett, Elizabeth Ching, Samuel F. Sears, Susanne S. Pedersen, Leopoldo Pozuelo & Mina K. Chung

  7. Department of Psychology, Tilburg University, Tilburg, The Netherlands

    Mohammed Qintar, Jason J. George, Melanie Panko, Scott Bea, Karen A. Broer, Julie St. John, Kecia-Ann Blissett, Elizabeth Ching, Samuel F. Sears, Susanne S. Pedersen, Leopoldo Pozuelo & Mina K. Chung

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  1. Mohammed Qintar
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Correspondence to Mina K. Chung.

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Mohammed Qintar and Jason J. George equal first authors.

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Qintar, M., George, J.J., Panko, M. et al. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety. J Interv Card Electrophysiol 43, 65–75 (2015). https://doi.org/10.1007/s10840-015-9990-7

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  • DOI: https://doi.org/10.1007/s10840-015-9990-7

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