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Behavioral Intervention

Intervention for Psychosocial Functioning

N/A

Waitlist Available

Led By Victoria Tang, MD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Scheduled major surgery with an anticipated hospital stay of 3+ days

≥ 65 years of age on the day of surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months postoperatively

Awards & highlights

Study Summary

This trial aims to test if problem solving therapy (PST) can help older adults who are having major surgery & are feeling depressed or lack social support.

Who is the study for?

This trial is for older adults who are about to have major surgery and either feel depressed or lack social support. It's designed to see if a type of counseling called Problem Solving Therapy (PST) can help them before and after the operation.Check my eligibility

What is being tested?

The study is testing Problem Solving Therapy (PST), which is a counseling technique aimed at improving mental health and potentially aiding recovery in older patients undergoing surgery.See study design

What are the potential side effects?

Since PST involves talking with a therapist, there aren't any physical side effects like you'd get with medicine. However, discussing sensitive issues might be emotionally challenging for some.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a major surgery that will require a hospital stay of more than 3 days.

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I am 65 years old or older on the day of my surgery.

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I have had major surgery, such as for bones, chest, abdomen, or heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postoperatively for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Functional Recovery

Secondary outcome measures

Depressive Symptoms

Other outcome measures

Anxiety

Cognition

Depressive symptoms

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Participants in the intervention arm will receive PST. Meetings via videoconferencing or phone will occur at a frequency of 1 time every week for an estimated 2-3 sessions before surgery and 6-7 sessions after surgery for a total of 9 sessions. PST: Essential components of the PST that the patient will be taught include: (1) define the nature of the problem, (2) generate wide range of possible solutions, (3) systematically evaluate the potential solutions and select the most optimal ones to implement, (4) monitor and evaluate the actual solution outcome after implementation.

Group II: Enhanced Usual CareActive Control1 Intervention

Participants in the control arm will receive "enhanced usual care". They will receive additional mental health education in the form of educational handouts mailed or emailed to them.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Problem Solving Therapy (PST)

2007

Completed Phase 1

~110

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,465 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,973 Total Patients Enrolled

Victoria Tang, MD, MASPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

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

Are investigators still actively seeking volunteers for this experiment?

"According to the data on clinicaltrials.gov, this trial is not engaging in recruitment at this time; it was initially posted February 1st 2024 and last updated December 8th 2023. Nevertheless, there are currently 1547 other medical studies that require participants."

Answered by AI

Recent research and studies

Implementation ScienceJournal

Psychometric Assessment of Three Newly Developed Implementation Outcome Measures

Weiner, Bryan J., Cara C. Lewis, Cameo Stanick, Byron J. Powell, Caitlin N. Dorsey, Alecia S. Clary, Marcella H. Boynton, and Heather Halko. 2017. “Psychometric Assessment of Three Newly Developed Implementation Outcome Measures”. Implementation Science. Springer Science and Business Media LLC. doi:10.1186/s13012-017-0635-3.

Journal of the American Geriatrics SocietyJournal

Recovery of Activities of Daily Living in Older Adults After Hospitalization for Acute Medical Illness

Boyd, Cynthia M., C. Seth Landefeld, Steven R. Counsell, Robert M. Palmer, Richard H. Fortinsky, Denise Kresevic, Christopher Burant, and Kenneth E. Covinsky. 2008. “Recovery of Activities of Daily Living in Older Adults After Hospitalization for Acute Medical Illness”. Journal of the American Geriatrics Society. Wiley. doi:10.1111/j.1532-5415.2008.02023.x.

clinicaltrials.govStudy

PST in Surgery: Feasibility and Acceptability Pilot

2024. "PST in Surgery: Feasibility and Acceptability Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06174701.