An interventional study of Cognitive Behavioral Therapy in Anxiety, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
This study will compare the effectiveness that Cognitive Behavioral Therapy has on decreasing the amount of anxiety, as well as the number of inappropriate firings that a patient with an ICD may experience.
This study is an interventional study of patients with ICDs followed in the Cleveland Clinic Device Clinic. Patients with ICDs experience some level of anxiety which can impact the number of shocks that they receive from their Device. 100 of these patients will be randomized into one of 2 groups; those receiving three sessions of Cognitive Behavioral Therapy (CBT) and those receiving usual care. We hypothesize that if these ICD patients receive short term (CBT) they will experience less anxiety and have a lower rate of device firings than the patients that did not receive CBT. Furthermore, we will study mechanistic pathways involved in the reduction of anxiety in ICD patients. We will extract initial heart rate variability (HRV) data from device interrogation. We hypothesize that the CBT intervention arm will have a higher normalization of HRV. Patients will repeat questionnaires at 3, 6 and 12 months.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →The Cleveland Clinic is the lead sponsor of 819 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three individual 45 minute cognitive behavioral therapy sessions over a 3 month period
Behavioral: Cognitive Behavioral Therapy
The Usual Care Arm will be the control arm. These patients will not be scheduled with any CBT sessions.
Three 45 minute CBT sessions scheduled over a 3 month period.
Patients in the CBT intervention arm will have a higher reduction in anxiety and experience better quality of life compared to usual care at 3 months.
Time frame: Patients in the CBT arm will have (3) 45min. sessions scheduled over a 3 month period.
Patients in the CBT intervention arm will have a lower rate of firings (shocks).
Time frame: Patients in both arms will have their ICD's interrogated at 3, 6 and 9 months.
Plan to share: No
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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