Evidence map›Paper›PMID 25779222›Full record

Observational studyJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2015

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.

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 and 2 more

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00851071 (Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00851071 nacompletednot on this map

Bakken Heart Brain Institute's "An Observational and Interventional Study of Anxiety Symptoms in the Implantable Cardioverter Defibrillator (ICD) Patient."

TypeinterventionalSponsorThe Cleveland ClinicRan2009 to 2017Enrolled28ConditionsAnxietyArmsCognitive Behavioral Therapy
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Observational
  6. Article
  7. Review
  8. Article
  9. Stereotactic radioablation for ventricular tachycardia.Herzschrittmachertherapie & Elektrophysiologie · 2022
    Review
  10. Article
  11. Cardiac sympathetic denervation and mental health.Autonomic neuroscience : basic & clinical · 2021
    Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Mohammed QintarDepartment of Internal Medicine, Cleveland Clinic, Cleveland, OH, USA.
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

Funding

Functional Genomics of Atrial Fibrillation in Human AtriaR01HL111314 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI BARNARD, JOHN, CHUNG, MINA KAY · 2012 to 2019
$6.1M
Genetics of Atrial FibrillationR01HL090620 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI BARNARD, JOHN, CHUNG, MINA KAY · 2008 to 2012
$2.9M
NHLBI NIH HHS R01 HL090620NHLBI NIH HHS R01 HL111314
6 · The paper itself

Abstract

purposeStress 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.

methodsThe 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.

resultsThe 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.

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

Indexed as

Cognitive Behavioral TherapyDefibrillators, ImplantableHeart FailureStress, PsychologicalFemaleHumansMaleMiddle AgedPilot ProjectsProspective StudiesTreatment Outcome

Identifiers

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.