Clinical trial NCT02088619: Positive Therapy for Autonomic Function & Mood in ICD Patients
Official title: Positive Psychotherapy to Improve Autonomic Function and Mood in ICD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrhythmia
Implantable Cardioverter Defibrillator
Keywords: psychological wellbeing
anxiety
depression
autonomic functioning
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-03-17
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of arrhythmias between baseline and 3-months
timeFrame: 3-months
measure: Frequency of arrhythmias between 3-months and 9-months
timeFrame: 9-months
Secondary outcomes:
measure: Frequency of ICD therapies between baseline and 3-months
timeFrame: 3-months
measure: Change in High Frequency heart rate variability (HF-HRV) between baseline and 3-months
timeFrame: 3-months
measure: Frequency of ICD therapies between 3-months and 9-months
timeFrame: 9-months
measure: Change in High Frequency heart rate variability (HF-HRV) between 3- and 9-months
timeFrame: 9-months
Other outcomes:
measure: Florida Shock Anxiety Scale
timeFrame: 3 months
measure: Florida Patient Acceptance Scale
timeFrame: 3-months
measure: Emotions Questionnaire
timeFrame: 3-months
measure: Center for Epidemiologic Studies - Depression Scale (CES-D)
timeFrame: 3-months
measure: State Trait Anxiety Inventory (STAI)
timeFrame: 3-months
measure: Life Orientation Test - Revised (LOT-R)
timeFrame: 3-months
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 3-months
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 3-months
measure: Quality of Life Inventory (QOLI)
timeFrame: 3-months
measure: Short-Form Health Survey-36 (SF-36)
timeFrame: 3-months
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: 3-months
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina, Dept of Psychiatry, Division of Bio-Behavioral Medicine
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Eva R Serber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frisch M. Quality of Life Therapy; Applying a Life Satisfaction Approach to Positive Psychology and Cognitive Therapy. Hobokon, NJ: John Wiley & Sons, Inc.; 2006.