Please select the outcome measures that correspond to the clinical trial below.
Title: Psychological Support for Patients With an Implantable Cardioverter Defibrillator
Brief Summary: About 30% of patients survive a cardiac arrest, and the majority of these receive an implantable cardioverter defibrillator (ICD) for prevention of sudden cardiac death (SCD). While ICD therapy offers survival benefit over drug therapy, there remain significant quality of life (QL) issues. About 50% of patients experience chronic anxiety about receiving an ICD shock. Anxiety and depression in turn appear to predispose to more arrhythmias necessitating ICD therapy. The aims of the current study are:

1. to evaluate a 8-session psychosocial intervention to help patients cope effectively with receiving an ICD for secondary prevention of SCD,
2. to determine if baseline measures of depression and anxiety predict ICD therapies (i.e., anti-tachycardia pace terminations and shocks); and
3. to explore if the psychosocial intervention results in less need for appropriate ICD therapies.


Options:
A: Feasibility - enrollment of 1-2 participants per month (One year)
B: Patient Health Questionaire (PHQ-9) (At 3- and 6- months following the death of the patient)
C: Hospital Anxiety and Depression Scale - Depression Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Depression Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Depression Scale at 12-months Follow-up (Twelve-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at Baseline (Baseline); Hospital Anxiety and Depression Scale - Anxiety Scale at 6-months Follow-up (Six-months follow-up); Hospital Anxiety and Depression Scale - Anxiety Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Total Score at Baseline (Baseline); Impact of Events Scale-Revised - Total Score at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Total Score at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at Baseline (Baseline); Impact of Events Scale-Revised - Intrusiveness Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Intrusiveness Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at Baseline (Baseline); Impact of Events Scale-Revised - Avoidance Scale at 6-months Follow-up (Six-months follow-up); Impact of Events Scale-Revised - Avoidance Scale at 12-months Follow-up (Twelve-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at Baseline (Baseline); Impact of Event Scale-Revised Hyperarousal Scale at 6-months Follow-up (Six-months follow-up); Impact of Event Scale-Revised Hyperarousal Scale at 12-months Follow-up (Twelve-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at Baseline (Baseline); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 6-months Follow-up (Six-months follow-up); Crown-Crisp Experiential Index - Phobic Anxiety Scale at 12-months Follow-up (Twelve-months follow-up)
D: Percent of Eligible Participants Who Provided Consent (pre-randomization); Percent of Eligible Participants Who Provide Informed Consent and Were Randomized (randomization); Client Satisfaction Questionnaire (CSQ) Score (1 month post-randomization); System Usability Scale (SUS) (1 month post-randomization); Percent of Randomized Participants Who Drop Out of Study (baseline, end of study (approx. 4 months)); Percent of Participants Who Have Neither Dropped Out Nor Died Who Complete Telephone Interviews (baseline, end of study (approx. 4 months)); Percent of Participants in the Self-directed MBT Group Who Complete Weekly Surveys (baseline, end of study (approx. 4 months)); Percentage of Self-directed MBT Sessions Attended by Eligible Participants (baseline, end of study (approx. 4 months)); Visual Analog Satisfaction Scale (after intervention completion, up to 8 weeks post-randomization); Number of Participant Clicks on Study Website (baseline, end of study (approx. 4 months))

Answer: C