Clinical trial · Interventional
Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery
NCT05685511CI-TRIAL-00106940completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Major Surgical Resection of an Abdominal Malignancy | — | UNRESOLVED | — |
| Major Surgical Resection of a Thoracic Malignancy | — | UNRESOLVED | — |
| Older Adults | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Activation | Behavioral | — | UNRESOLVED |
| Medication Optimization | Other | — | UNRESOLVED |
| Usual care resources | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- 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.
- interventionNames
- Other: Usual care resources
- type
- EXPERIMENTAL
- label
- Intervention Bundle (Behavioral Activation + Medication Optimization)
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 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: * Adults age ≥60 years * Scheduled major thoracic, breast, or abdominal surgery for suspected or confirmed malignancy * PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥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 * Considered ineligible per the discretion of the oncologic surgeon or study PI * Previous participation in this study or another CPMH study of the intervention bundle or its feasibility.
References
Publications (1)
- DERIVEDHolzer KJ, Bartosiak KA, Calfee RP, Hammill CW, Haroutounian S, Kozower BD, Cordner TA, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Miller JP, Politi MC, Zhang Y, Yingling MD, Baumann AA, Kannampallil T, Schweiger JA, McKinnon SL, Avidan MS, Lenze EJ, Abraham J. Perioperative mental health intervention for depression and anxiety symptoms in older adults study protocol: design and methods for three linked randomised controlled trials. BMJ Open. 2024 Apr 3;14(4):e082656. doi: 10.1136/bmjopen-2023-082656. PMID 38569683