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April 22, 2010Psychosomatic Medicine

A Randomized Controlled Trial of Secondary Prevention of Anxiety and Distress in a German Sample of Patients With an Implantable Cardioverter Defibrillator

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Key result

A 6-month psychological intervention improved anxiety (p<0.01), distress (p<0.02), and somatic quality of life (p<0.01) in ICD patients <65 years, but deteriorated these outcomes in older patients.

Why the study?

Does additional psychological treatment improve anxiety and quality of life in patients with an implantable cardioverter defibrillator?

Population

119 patients with an implantable cardioverter defibrillator from a German sample, assessed immediately after…

Comparison

Written information on medical and psychological… vs Usual medical aftercare alone

Design

RCT, assigned randomly

Follow-up

6 months

Authors

ACAlexander CrössmannUniversity of WürzburgSSStefan M. SchulzUniversität TrierVKVolker KühlkampMedizin Campus Bodensee

Discussion

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Implication

Psychological intervention may benefit younger ICD patients but risks worsening outcomes in older ones; challenges uniform application and supports age-stratified trials.

Key Points

  • To assess the efficacy of a low-intensity psychological intervention combining written education and phone counseling in reducing anxiety and improving quality of life in patients receiving an implantable cardioverter defibrillator.
  • Randomized controlled trial of 119 German patients assigned to either usual medical aftercare (n = 63) or psychological treatment (n = 56).
  • The intervention provided written information regarding medical and psychological consequences of device implantation along with 6 months of individual phone counseling.
  • Treatment efficacy was assessed by comparing baseline measures immediately post-implantation (T0) to follow-up evaluations at 6 months (T1).
  • Age moderated treatment efficacy: treated patients aged <65 years experienced improvements in anxiety (HADS-Anxiety, p < .01), psychological distress (SCL-K-9, p < .02), and physical quality of life (SF-36-PCS, p < .01), whereas patients aged 65–75 years experienced clinical deterioration.
  • Frequency of device shocks was associated with significant increases in depression, avoidance behaviors, and device-related constraints across all patients from baseline to 6 months (all p < .05).

Study Design

Type

RCT (n=119)

Randomization

randomly assigned

Structured PICO

Does additional psychological treatment improve anxiety and quality of life in patients with an implantable cardioverter defibrillator?

P
Population
119 patients with an implantable cardioverter defibrillator (ICD) randomized to usual care or a 6-month psychological intervention.
I
Intervention
Written information on medical and psychological consequences of an ICD plus 6 months of individual phone counseling added to usual medical aftercare
C
Comparator
Usual medical aftercare alone
O
Outcome
Anxiety (HADS-Anxiety), psychological distress (SCL-K-9), and somatic quality of life (SF-36-PCS) at 6 monthspatient reported

A minimal psychological intervention improved anxiety and quality of life in younger ICD patients (<65 years) but worsened these outcomes in older patients (65-75 years).

Cite This Study

Crössmann et al. (2010) conducted an RCT in implantable cardioverter defibrillator (ICD) (n=119). written information plus 6 months of individual phone counseling vs. usual medical aftercare was evaluated on anxiety (HADS-Anxiety), psychological distress (SCL-K-9), and somatic quality of life (SF-36-PCS). A 6-month psychological intervention improved anxiety (p<0.01), distress (p<0.02), and somatic quality of life (p<0.01) in ICD patients <65 years, but deteriorated these outcomes in older patients.

synapsesocial.com/papers/6a71c56ec2d7c30908271e4chttps://doi.org/10.1097/psy.0b013e3181d9bcec

Topics

Cardiac device therapy
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Anxiety and Depression in Patients Receiving Implanted Cardioverter-Defibrillators: A Longitudinal Investigation1997 · 141 citations
  2. 2Implantable cardioverter defibrillators: physical and psychosocial outcomes1997 · 44 citations
  3. 3Clustering of Device‐Related Concerns and Type D Personality Predicts Increased Distress in ICD Patients Independent of Shocks12007 · 56 citations
  4. 4Affective Distress and Implantable Cardioverter Defibrillators: Cases for Psychological and Behavioral Interventions1999 · 45 citations
  5. 5Association of mood disturbance and arrhythmia events in patients after cardioverter defibrillator implantation1999 · 115 citations