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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05575128
Other study ID # 202209033
Secondary ID P50MH122351
Status Recruiting
Phase N/A
First received
Last updated
Start date November 5, 2022
Est. completion date March 31, 2025

Study information

Verified date February 2024
Source Washington University School of Medicine
Contact Theresa Cordner, BS
Phone 3142737921
Email cordnert@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Hybrid 1 Study will test the effectiveness of a bundled intervention comprised of behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing cardiac surgery (compared with usual care), while examining implementation outcomes.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 31, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion criteria: - Adults = 60 years - Scheduled major cardiac procedure - PHQ-ADS = 10, indicating clinically significant depression or anxiety symptoms Exclusion criteria: - Barrier to communication (Unable to read, speak, and understand English) - Severe cognitive impairment screened by the SBT (Short Blessed Test) >10 - Acutely suicidal - Previous participation in this study or CPMH feasibility study 202101103.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavioral activation
The behavioral intervention will consist of behavioral activation (BA), the basic premise of which is to help people with mental health problems to engage in activities that are reinforcing or meaningful and guided by their personal values
Other:
Medication optimzation
Medication optimization consists of a simple set of principles: reconcile patient's medications, identify the patient's likely need for, and interest in, a medication adjustment, make the adjustment, and assess the response to that adjustment.
Care as usual
Care as usual, with written resources provided

Locations

Country Name City State
United States Washington University in St. Louis Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PHQ-ADS PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores will be compared between the two study arms 3 months after surgery.
PHQ-ADS is a composite measure of anxiety and depression. PHQ-ADS scores can range from 0 to 48 (with higher scores indicating more severe depression/anxiety)
3 months post-operatively
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