Anxiety, Cardiac Surgery, Depression, Older Adults
Conditions
Keywords
Behavioral activation, medication optimization, cardiac surgery, perioperative mental health
Brief 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.
Interventions
BEHAVIORALBehavioral 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
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.
OTHERCare as usual
Care as usual, with written resources provided
Sponsors
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Study staff responsible for administering ratings and collecting outcomes throughout the study are blinded. The investigator(s) are also blinded. This blinding is kept throughout the study until data collection is complete. At the end of the follow-up, the study coordinator will complete a blinding question to try to guess the arm to which each participant was allocated.
Intervention model description
Hybrid Type 1 effectiveness-implementation randomized controlled trial design
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-ADS | baseline and 3 months post-operatively | Change in PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) scores from baseline to 3 months postoperatively 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSimon Haroutounian, PharmD
Washington University School of Medicine
Participant flow
Pre-assignment details
1,233 cardiac patients were assessed for eligibility, 687 did not meet inclusion criteria, 369 declined participation, and 72 were excluded for other reasons.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 5.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 83 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 53 | 1 / 52 |
| other Total, other adverse events | 0 / 53 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
None listed