Clinical trial · Interventional
Behavioral Activation and Medication Optimization for Perioperative Mental Health Feasibility Study
- 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)
Inadequate management of preoperative mental health disorders often contributes to poor postoperative outcomes, including increased rates of readmission, delirium, falls, and mortality. However, very little work has been done to improve perioperative mental health. In particular, there have been limited systematic efforts that identify evidence-based behavioral and pharmacological strategies that were originally developed for depression and anxiety in otherwise medically well psychiatric patients. A mental health intervention bundle, composed of behavioral and pharmacological strategies, can mitigate anxiety and depression symptoms during the perioperative period. However, lacking is conclusive evidence on effectiveness of such an intervention bundle focused on the delivery of perioperative mental health care in older surgical patients. Towards this end, the investigators will develop and test an intervention bundle that encompasses: (1) behavioral activation, and (2) medication optimization.
Conditions
Conditions (7)
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 | — |
| Cardiac Surgery | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Major Surgical Resection of an Abdominal Malignancy | — | UNRESOLVED | — |
| Major Surgical Resection of a Thoracic Malignancy | — | UNRESOLVED | — |
| Older Adults | — | UNRESOLVED | — |
| Orthopedic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Activation | Behavioral | — | UNRESOLVED |
| Medication Optimization | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient Participants
- description
- * Behavioral activation (BA) will span across 3 months postoperatively \& will begin pre-operatively, with sessions approximately weekly or biweekly, depending on patient preference \& health condition. * 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.
- interventionNames
- Behavioral: Behavioral Activation
- Other: Medication Optimization
Primary outcomes (2)
- measure
- Reach of the Study as Measured by the Number of Participants Who Agree to Participate in the Study Out of the Total Eligible Participants
- timeFrame
- Through completion of the study (13 months and 5 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria Patient Participants * Age ≥60 years on the day of surgery; * Scheduled major orthopedic surgery, or major surgical resection of a thoracic or abdominal malignancy, or major cardiac procedure; * Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10 Exclusion Criteria Patient Participants * Estimated life expectancy \< 12 months; * Unable to read, speak, and understand English; * Current alcohol or other substance abuse; * Severe cognitive impairment screened by the SBT (Short Blessed Test) \>10; * Acutely suicidal
References
Publications (2)
- DERIVEDAbraham J, Meng A, Baumann A, Holzer KJ, Lenard E, Freedland KE, Lenze EJ, Avidan MS, Politi MC. A multi- and mixed-method adaptation study of a patient-centered perioperative mental health intervention bundle. BMC Health Serv Res. 2023 Oct 27;23(1):1175. doi: 10.1186/s12913-023-10186-3. PMID 37891574
- DERIVEDAbraham J, Holzer KJ, Lenard EM, Freedland KE, Tellor Pennington BR, Wolfe RC, Cordner TA, Baumann AA, Politi M, Avidan MS, Lenze E. Perioperative mental health intervention bundle for older surgical patients: protocol for an intervention development and feasibility study. BMJ Open. 2022 Aug 23;12(8):e062398. doi: 10.1136/bmjopen-2022-062398. PMID 35998971