NCT03798548

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 10, 2019

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

January 3, 2019

Last Update Submit

January 8, 2019

Conditions

Depression, Anxiety

Keywords

CBTBrief TherapyBedside Intervention

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Score on Beck Depression Inventory II (BDI-II)

    21-item self-report questionnaire with good reliability and validity in assessing symptoms of depression. Total score range 0-63 with higher scores indicating a worse outcome. Total BDI-II scores are interpreted as follows, 0-13: minimal, 14-19: mild, 20-28: moderate, 29-63: severe. In this study, a score of 14 or greater, and 20 or greater, were used define subpopulations with significant symptoms of depression on the BDI-II.

    An average of 3 days post TAVR Procedure, 1-Month Follow Up

Secondary Outcomes (3)

  • Change from Baseline Score on State Trait Anxiety Inventory Form YI (STAI-YI)

    An average of 3 days post TAVR Procedure, 1-Month Follow Up

  • Change from Baseline Score on Minnesota Living With Heart Failure Questionnaire (MLHFQ)

    1-Month Follow Up

  • Change from Baseline Score on 12-Item Short Form Health Survey (SF12v2)

    1-Month Follow Up

Study Arms (2)

Brief Bedside CBT

EXPERIMENTAL
Behavioral: Brief Bedside CBT

Treatment As Usual

NO INTERVENTION

Interventions

Brief Bedside CBTBEHAVIORAL

4 sessions of CBT including psychoeducation about TAVR and how mood can impact recovery in cardiac patients, discussion of patients' expectations and any concerns. Teaching and practice of cognitive restructuring and behavioral goal setting techniques for a healthy recovery.

Brief Bedside CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21621227BACKGROUND

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Brief Bedside CBT versus Treatment As Usual
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 3, 2019

First Posted

January 10, 2019

Study Start

January 15, 2015

Primary Completion

March 31, 2017

Study Completion

May 15, 2017

Last Updated

January 10, 2019

Record last verified: 2019-01