Clinical trial NCT03798548: Brief CBT for Patients Undergoing TAVR
Official title: Brief Cognitive Behavioral Therapy for Patients Undergoing Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: CBT
Brief Therapy
Bedside Intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Brief Bedside CBT versus Treatment As Usual
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Score on Beck Depression Inventory II (BDI-II)
timeFrame: An average of 3 days post TAVR Procedure, 1-Month Follow Up
Secondary outcomes:
measure: Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI)
timeFrame: An average of 3 days post TAVR Procedure, 1-Month Follow Up
measure: Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ)
timeFrame: 1-Month Follow Up
measure: Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2)
timeFrame: 1-Month Follow Up
Other outcomes:
Locations:
Study officials:
References:
citation: Dao TK, Youssef NA, Armsworth M, Wear E, Papathopoulos KN, Gopaldas R. Randomized controlled trial of brief cognitive behavioral intervention for depression and anxiety symptoms preoperatively in patients undergoing coronary artery bypass graft surgery. J Thorac Cardiovasc Surg. 2011 Sep;142(3):e109-15. doi: 10.1016/j.jtcvs.2011.02.046. Epub 2011 May 28.