An interventional study of Behavioral Activation and Medication Optimization in Older Adults, Anxiety and Depression, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
Using a Hybrid Type 1 Effectiveness-Implementation randomized control trial (RCT) design, the investigators will test the effectiveness of a bundled behavioral activation and medication optimization in reducing symptoms of depression and anxiety in older adults undergoing oncologic surgery (compared with usual care), while examining implementation outcomes.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 105 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Pre-screening:
To be considered for participation, patients will be screened using PHQ-4 questionnaire. Scores >3 will indicate positive pre-screen (i.e. can be considered for participation and formal screening). Scores \< 3 will indicate negative screen (i.e. patient not considered for formal screening due to low risk for anxiety or depression).
Screening:
Exclusion Criteria:
Patients will receive resources either by mail or email. The resources include options for exploring brain health, supporting sleep and mental health, and introducing community resources for older adults.
Other: Usual care resources
* Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately every two weeks. After discharge, the behavioral intervention will continue for 10-12 sessions, or out to approximately 3 months postoperatively. * Medications will be reviewed \& optimized by a team of interventionists including a psychiatrist, pharmacologist, \& pharmacists. While the participant is in-hospital, the interventionist's role will include coordinating with the hospital team to ensure that medication changes that were introduced preoperatively are maintained in-house \& that no new inappropriate medications are initiated. After discharge, \& up to approximately 3 months postoperatively, the interventionist will ensure that medication changes are reconciled during transitions of care. The interventionists will ensure the agreed-upon changes are implemented, or an alternative course of action is justified.
Behavioral: Behavioral Activation · Other: Medication Optimization
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.
List of resources that the patient can explore on their own
PHQ-ADS
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. 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).
Time frame: Baseline and 3 months post-operatively
| Milestone | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care |
|---|---|---|
| Started | 53 | 52 |
| Completed | 47 | 51 |
| Not completed | 6 | 1 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Medical condition | 1 | 0 |
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. 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).
| points | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care | Total |
|---|---|---|---|
| Baseline | 18.35 ± 1.35 | 16.67 ± 1.52 | 17.51 ± 1.14 |
| Month 1 | 10.95 ± 1.37 | 12.52 ± 1.53 | 11.74 ± 1.15 |
| Month 3 | 9.39 ± 1.40 | 12.65 ± 1.52 | 11.02 ± 1.16 |
Collected over From randomization through completion of study (estimated to be 4-6 months).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Bundle (Behavioral Activation + Medication Optimization) | 2/53 (3.8%) | 0/53 (0%) | 1/53 (1.9%) |
| Usual Care | 1/52 (1.9%) | 0/52 (0%) | 0/52 (0%) |
| Event | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care |
|---|---|---|
| Bump on the head due to a fallInjury, poisoning and procedural complications | 1/53 | 0/52 |
| Age, Continuous(years) | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care | Total |
|---|---|---|---|
| Mean | 67.6 ± 6.2 | 66.9 ± 6.6 | 67.3 ± 6.4 |
| Sex: Female, Male(Participants) | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care | Total |
|---|---|---|---|
| Female | 42 | 42 | 84 |
| Male | 10 | 6 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 52 | 48 | 100 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 7 | 15 |
| White | 44 | 41 | 85 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intervention Bundle (Behavioral Activation + Medication Optimization) | Usual Care | Total |
|---|---|---|---|
| United States | 52 | 48 | 100 |
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Washington University School of Medicine