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NCT00624520 · ClinicalTrials.gov registry record · Phase 3

Mental Stress Reduction in Defibrillator Patients

A Phase 3 study, sponsored by US Department of Veterans Affairs.

Terminated
Registry status
Phase 3
Development phase
129
Enrollment target

NCT00624520: Clinical Trial Phase 3 study, sponsored by US Department of Veterans Affairs.

NCT00624520 is a Phase 3 study that was terminated before completion, run by US Department of Veterans Affairs. The registered enrollment target is 129 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00624520, a Phase 3 study, was terminated before completion, sponsored by US Department of Veterans Affairs.

TERMINATED
Registry status
Phase 3
Development phase
129 participants
Enrollment target

Study Summary

The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators

Primary Outcome

Maximum Mental Stress induced elevation in "Double Product" , (equal to Heart Rate , beats/minute, x Systolic Arterial Blood Pressure, mmHg), following serial heart rate and blood pressure measurements during mental stress task of mental arithmetic (serial subtraction). Heart rate and blood pressure responses were recorded at 2.5 minute intervals before , during, and after each test using a Philips automated blood pressure recording device. The math task was applied for 10 minutes, with 10 minut

Interventions

  • OTHER Patient Education
  • BEHAVIORAL Cognitive Behavioral Stress Management (CBSM)

Trial Details

FieldValue
Enrollment Target 129 participants
Start Date 2008-09
Est. Completion 2014-07
Phase Phase 3
US Department of Veterans Affairs

632 total trials

Why NCT00624520 stopped before completion

NCT00624520 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 2 interventions - of which Patient Education is the first listed.

NCT00624520 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00624520 about?

NCT00624520 is a clinical study titled "Mental Stress Reduction in Defibrillator Patients". The purpose of this study is to assess the effectiveness of a 10 week program of Stress Management versus control Patient Education sessions on cardiac responses to mental stress in veterans with Implantable Cardioverter-Defibrillators

What is the current status of trial NCT00624520?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 129 participants. The study started on 2008-09. Estimated completion is 2014-07.

What interventions are being tested in trial NCT00624520?

The interventions under investigation include: Patient Education (OTHER), Cognitive Behavioral Stress Management (CBSM) (BEHAVIORAL).

Who is sponsoring clinical trial NCT00624520?

This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00624520's enrollment target sits among peer trials

129 1597th of 2000 higher than 400 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00624520, the US trial registry maintained by the National Library of Medicine. NCT00624520 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.