MedTrace Logo

Sleep and Ventricular Arrhythmias Study

NCT02232204 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2014-09-05

No results posted yet for this study

Summary

This is a single-center, randomized controlled trial study design. Enrolled participants have a cardiovascular condition for which they are undergoing implantable cardioverter defibrillator (ICD) therapy and comorbid insomnia. Participants were randomized to a behavioral intervention for insomnia in ICD patients or a waitlist control. The treatment intervention period lasted 4 weeks with a telephone booster session administered at 3 month follow-up. The objective of the study is to examine the impact of a brief therapy combining established behavioral approaches to treating insomnia with novel components to target negative cognitions and anxieties associated with cardiac disease and ICD implantation. Primary patient outcomes include sleep, psychological functioning, daytime functioning, cardiac functioning, cognitive performance, and ICD adjustment.

Conditions

  • Cardiac Arrhythmia
  • Implantable Defibrillator User
  • Insomnia

Interventions

BEHAVIORAL

CBT for Insomnia in ICD Patients (CBT-I-ICD)

Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • Christina S McCrae, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-10-31
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02232204 on ClinicalTrials.gov