Brief CBT for Patients Undergoing TAVR

Stanford University

Status: Completed

Conditions: Depression, Anxiety

Treatments: Behavioral: Brief Bedside CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03798548

32178

Details and patient eligibility

About

Adult patients scheduled to undergo TAVR were randomized to receive brief bedside cognitive behavioral therapy for depression/anxiety or treatment as usual.

Full description

Depression and anxiety are common symptoms in patients undergoing cardiac surgery and associated with increased cardiac morbidity and decreased functional status. Cognitive behavioral therapy (CBT) has been shown to be an effective intervention to treat these symptoms after cardiac surgery, but has not yet been studied in patients undergoing less invasive cardiac procedures such as Transcatheter Aortic Valve Replacement (TAVR). This study will examine the effect of CBT on symptoms of anxiety and depression in patients undergoing TAVR.

The CBT protocol was loosely structured on the Managing Depression and Anxiety using Education and Skills (MADES) protocol described in Dao and colleagues (2011). The current intervention was designed to address the needs of individuals who may develop anxiety or depression symptoms post-TAVR. The CBT intervention consisted of four 30 to 60-minute bedside treatment sessions with a trained clinician while the participant was hospitalized for TAVR.

Main outcome measures were self-reported symptoms of depression and anxiety as measured by the Beck Depression Inventory-II and State Trait Anxiety Inventory Form Y1. Secondary outcomes included health related quality of life and hospital length of stay.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults 18 years of age and older
2. Voluntary participation
3. Informed consent obtained
4. Patients with severe aortic stenosis and high surgical risk who are undergoing TAVR

Exclusion criteria

1. Current psychiatric instability (eg., suicidality, schizophrenia, bipolar disorder, active alcoholism or substance abuse)
2. Severe cognitive impairment, i.e. dementia
3. Life threatening co-morbidities
4. Inability to provide consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups

Brief Bedside CBT

Experimental group

Treatment:

Behavioral: Brief Bedside CBT

Treatment As Usual

No Intervention group