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Therapy & Meds for Depression & Anxiety in Aging Adults With Cancer

N/A

Recruiting

Led By Benjamin D Kozower, M.D., MPH

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-month follow-up, and 3-month follow-up

Awards & highlights

Study Summary

This trial will test if a combination of therapy & meds can reduce depression & anxiety in older adults with cancer.

Who is the study for?

This trial is for adults aged 60 or older who are about to have major surgery for suspected or confirmed tumors in the chest or abdomen. They must show signs of depression or anxiety based on specific questionnaires (PHQ-4 and PHQ-ADS). People with severe cognitive issues, suicidal thoughts, previous participation in similar studies, communication barriers, or deemed ineligible by the surgeon can't join.Check my eligibility

What is being tested?

The study is testing a combination of behavioral activation and medication optimization to see if it helps reduce depression and anxiety symptoms better than usual care in aging adults having cancer surgery. It's a randomized control trial which means participants will be randomly assigned to either the new treatment bundle or standard care.See study design

What are the potential side effects?

While not explicitly stated here, side effects may include typical reactions to changes in medication regimens such as nausea, dizziness, headaches, and potential psychological impacts from behavioral interventions like increased anxiety during adjustment periods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-month follow-up, and 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-month follow-up, and 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-month follow-up, and 3-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in anxiety as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Change in depression as measured by the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Bundle (Behavioral Activation + Medication Optimization)Experimental Treatment2 Interventions

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.

Group II: Usual CareActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Activation

2013

Completed Phase 3

~2940

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,942 Previous Clinical Trials

2,304,185 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,794 Previous Clinical Trials

2,693,780 Total Patients Enrolled

Benjamin D Kozower, M.D., MPHPrincipal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

440 Total Patients Enrolled

Media Library

Behavioral Activation Clinical Trial Eligibility Overview. Trial Name: NCT05685511 — N/A

Abdominal Cancer Surgery Research Study Groups: Usual Care, Intervention Bundle (Behavioral Activation + Medication Optimization)

Abdominal Cancer Surgery Clinical Trial 2023: Behavioral Activation Highlights & Side Effects. Trial Name: NCT05685511 — N/A

Behavioral Activation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05685511 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this experimentation?

"Unfortunately, the intelligence available on clinicaltrials.gov suggests that this specific trial is not presently recruiting patients; its first posting date was February 28th 2023 and it's last update occurred on January 5th 2023. However, there are 3,661 other medical studies actively looking for participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery

2023. "Behavioral Activation and Medication Optimization For Improving Perioperative Mental Health In Older Adults Undergoing Oncologic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05685511.