Positive Therapy for Autonomic Function & Mood in ICD Patients

Ventricular Arrhythmia Clinical Trial

— PAM-ICD  

Official title:

Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088619
• Other study ID #: Pro00028869
• Secondary ID: 1R34HL107733-01A
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: September 29, 2017
• Start date: July 2014
• Est. completion date: January 2017

Study information

• Verified date: September 2017
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this 2-group randomized clinical trial is to: 1) examine the feasibility and acceptability of a 3-month positive-emotion focused therapy (Quality of Life Therapy) modified specifically for patients with implantable cardioverter defibrillator (ICD); and 2) obtain estimates of effect size for QOLT compared to Heart Healthy Education on the changes in arrhythmia frequency and biomarkers of autonomic function, as well as changes in emotion, mood, and well-being across time (baseline, 3 & 9-months). It is hypothesized that the QOLT will promote improvements in autonomic function, reduced arrhythmia frequency, and improved psychological well-being.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult men and women (=18 years of age) who have received an ICD for primary or secondary prevention of sudden cardiac death. All patients will have systolic left ventricular dysfunction due to coronary disease or nonischemic cardiomyopathy. There is no requirement for time since implant;

2. Score =5 on the Hospital Anxiety and Depression Scale (HADS) anxiety or depression scales;

3. Able to read and write English

4. Able to commit to the 3-month QOLT/HHE program and 3 assessments over a 9-month duration.

Exclusion Criteria:

1. >5% atrial or ventricular pacing;

2. Sinus node dysfunction;

3. Persistent and permanent atrial fibrillation (AF) (h/o of paroxysmal AF will be allowed).

4. Long QT syndrome; and other channelopathies such as Brugada syndrome;

5. Hypertrophic cardiomyopathy;

6. Neurocognitive or cognitive impairments;

7. Severe psychopathology that warrants intensive treatment;

8. Participation in another research trial; and

9. Currently in psychological or psychiatric treatment.

10. Current psychotropic and cardiac medication prescriptions and usage need to be stable (i.e., no change in type or dosage) for 3-months prior to study enrollment.

Related Conditions & MeSH terms

• Implantable Cardioverter Defibrillator
• Ventricular Arrhythmia

Intervention

Behavioral:
• Quality of Life Therapy (QOLT)

• Heart Healthy Education (HHE)

Locations

Country	Name	City	State
United States	Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Florida Shock Anxiety Scale		3 months
Other	Florida Patient Acceptance Scale		3-months
Other	Emotions Questionnaire		3-months
Other	Center for Epidemiologic Studies - Depression Scale (CES-D)		3-months
Other	State Trait Anxiety Inventory (STAI)		3-months
Other	Life Orientation Test - Revised (LOT-R)		3-months
Other	Positive and Negative Affect Schedule (PANAS)		3-months
Other	Satisfaction with Life Scale (SWLS)		3-months
Other	Quality of Life Inventory (QOLI)		3-months
Other	Short-Form Health Survey-36 (SF-36)		3-months
Other	Minnesota Living with Heart Failure Questionnaire (MLHFQ)		3-months
Primary	Frequency of arrhythmias between baseline and 3-months	Total arrhythmia frequencies between baseline and 3-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( =6 beats, at >120 beats per minute [BPM] ) plus arrhythmias detected by the ICD	3-months
Primary	Frequency of arrhythmias between 3-months and 9-months	Total arrhythmia frequencies between 3-months and 9-months will be the sum of non-sustained ventricular tachycardia (NSVT) detected on the Holter ( =6 beats, at >120 BPM ) plus arrhythmias detected by the ICD	9-months
Secondary	Frequency of ICD therapies between baseline and 3-months	Obtained from ICD interrogation reports from recording between baseline and 3-months	3-months
Secondary	Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months	Index of parasympathetic activity; obtained from 24-hour Holter recording	3-months
Secondary	Frequency of ICD therapies between 3-months and 9-months	Obtained from ICD interrogation reports between 3- and 9-months	9-months
Secondary	Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months	Index of parasympathetic activity; obtained from 24-hour Holter recording	9-months