Building Resilience for Surgical Recovery (BRSR)

April 28, 2025 updated by: Victoria Tang, The University of Texas Health Science Center, Houston

Building Resilience for Surgical Recovery: Feasibility and Acceptability Pilot Study

The goal of this clinical trial is to test problem solving therapy (PST) in older adults who are undergoing major surgery. The main question it aims to answer is: What is the feasibility and acceptability of delivering PST to older surgical patients with depressive symptoms or report lacking social support in the pre-operative and post-operative setting?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A pilot test of a 9-session psychosocial intervention (Problem Solving Treatment, PST) will be conducted at the University of Texas, Southwestern Medical Center (UTSW). Ninety older surgical patients will be recruited from UTSW's Peri-operative Senior Health (POSH) clinic, with 20 for training, 35 randomized to the intervention arm, and 35 in the control arm. Preliminary data from this study will inform an R01 submission assessing the impact of PST on post-operative functional recovery.

Summary of Objectives:

  1. Examine the feasibility of implementing an evidence-based psychosocial intervention, PST, for older surgical patients with depressive symptoms.
  2. Demonstrate the acceptability of the intervention delivery for older surgical patients with depressive symptoms.
  3. Evaluate the potential improvement in function and reduction in depressive symptoms.

Setting:

Ninety older adults undergoing major surgery will be recruited at the UTSW POSH clinic during the pre-operative period over a 6-month time frame. UTSW POSH sees 15-20 older surgical patients pre-operatively a week.

Recruitment and Enrollment:

Participants will be recruited through two pathways - clinician referral and self-referral. (1) Clinician referral: clinicians will refer via recruitment flyer, by the clinic team at the clinic visit, or via email to the study team. (2) Self-referral: recruitment flyers will be utilized in waiting rooms and clinical offices for interested patients to contact the study team.

Clinician Referral Details:

Clinicians will provide the research team with the patient's name and phone number for recruitment if they believe the patient is experiencing depressive symptoms and has a life expectancy of more than 6 months. The study team will reach out to the patient to recruit them into the study.

Enrollment and Consent:

Enrollment and consent will be conducted over the phone, and consent forms with DocuSign will be sent via email. To reduce discrimination against older adults unfamiliar with the technology, those unable to sign the consent form via DocuSign will be mailed the paper consent form with return postage to sign and send back. Consent will be stored in RedCAP.

Training of Interventionists:

Interventionists will undergo training with a problem-solving therapy master trainer. Participants will be recruited for this training until all interventionists meet criteria for intervention delivery. Refer to the training participant consent form for details.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Victoria Tang, MD, MAS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • ≥ 65 years of age on the day of surgery
  • Scheduled major surgery with an anticipated hospital stay of 3+ days. Major operations include: orthopedic, thoracic or abdominal, cardiac procedures
  • Depressive symptoms - Patient Health Questionnaire (PHQ-9) screening with a score of 5+, 5-9 being subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, we need to have at least one of these items included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2)

Exclusion criteria:

  • Those with severe cognitive impairment - Short Portable Mental Status Questionnaire (SPMSQ) screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment
  • Unable to read, speak, and understand English
  • Current alcohol or other substance abuse (scoring 2+ on CAGE questionnaire or answering yes to "Do you currently use any non-prescription drugs or substances?")
  • Life expectancy is 6 months or less

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Problem Solving Therapy (PST)
Participants in the intervention arm will receive Problem Solving Therapy (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. 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, and (4) monitor and evaluate the actual solution outcome after implementation.
Behavioral: Problem Solving Therapy (PST)
PST intervention in the form of one-on-one coaching in preparation for surgery and post-operative care. This coaching consists of educating and guiding the patient in developing problem-solving skills. Please refer to the PST Handbook for further detail on the therapy sessions.
Experimental: Enhanced Usual Care
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.
Behavioral: Enhanced Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)
Time Frame: 6 months after baseline
6-month functional recovery is measured by a comparison of the pre- and post-operative function using self-report to the World Health Organization Disability Assessment Schedule (Brief-WHODAS). Brief-WHODAS is a 12-item questionnaire where scores assigned to each of the items ["none" (0), "mild" (1), "moderate" (2), "severe" (3), and "extreme" (4)] are summed. The "summary score" is then converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). The rationale for using 6 months for follow-up is that after a major surgery, older adults can take up to 6 months to recover to their new functional baseline and has been used in previous studies.
6 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive Symptoms as Assessed by Score on the by the Patient Health Questionnaire (PHQ-9)
Time Frame: 3 months and 6 months after baseline
The secondary outcome is 3 and 6-month depressive symptoms, as measured by the Patient Health Questionnaire (PHQ-9). It is a 9-item questionnaire in which each item can be scored as 0 - Not at all, 1 - Several days, 2 - More than half the days, or 3 - Nearly every day. The total score is obtained by summing the scores for each of the nine items, resulting in a total score range from 0 to 27. 0 indicates no/minimal depression, and 27 indicates severe depression.
3 months and 6 months after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical pain
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Brief Pain Inventory (BPI) (1 question from the 11 questions) - "Throughout our lives, most of us have had pain from time to time (such as minor headaches, sprains, and toothaches). Have you had pain other than these everyday kinds of pain today?" Yes to indicate pain and no to indicate no pain.
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Cognition
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
The Short Portable Mental Status Questionnaire (SPMSQ) (10-items) for assessment of cognitive function in older adults. Scoring scale of 0-8: Screening with a score of 5+ errors, 5-8 being moderate to severe cognitive impairment.
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Depressive symptoms
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Measured by the Patient Health Questionnaire (PHQ-9), a 9-item self-report questionnaire assesses depression to gauge the severity of depression over the past two weeks. Screening with a score of 5+, 5-9 indicating subclinical depression and scores up to 27 indicating increasing depression. If the score is 5-9, at least one of these items needs to be included: "at least one of the endorsed items needs to be depressed mood or diminished activities" (questions #1 and #2).
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Self-efficacy
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
As measured by General Perceived Self-efficacy Scale (GSE). A 10-item questionnaire with the total score being the sum of the all items. Scores range from 0-40 with a higher score indicating more self-efficacy.
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Anxiety
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
As measured by General Anxiety Disorder (GAD-7). A 7-item questionnaire with a score of 0-4 indicating minimal anxiety; 5-9 indicating mild anxiety; 10-14 indicating moderate anxiety; 15-21 indicating severe anxiety. Anxiety will also be measured by the Behavioral Activation for Depression Scale Short Form (BADS-SF). A 9-item questionnaire with 6 items focusing on activation and 3 items focusing on avoidance. The range of scores is 0 to 54, with high scores representing higher activation.
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Social Support
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
As measured by Patient-Reported Outcomes Measurement Information System (PROMIS)- Emotional support and instrumental support questions. Scores for each set up questions range from 8-40 where 8 indicates no social support and 40 indicates social support. The initial collection will be used as the baseline measure against which subsequent collections will be compared.
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
Physical Function
Time Frame: Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.
As measured by World Health Organization Disability Assessment Schedule 2.0 (Brief-WHODAS), as this is a community dwelling older adult population and this scales from activity of daily living (ADL) to participation in society. Brief-WHODAS is a 12-item questionnaire where scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed. The "summary score" is them converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability). Will also be measured by Katz Index of Independence in Activities of Daily Living (ADL) and Lawton Instrumental Activities of Daily Living Scale (IADL).
Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Institute on Aging (NIA)
University of California, San Francisco

Investigators

  • Principal Investigator: Victoria Tang, MD, MAS, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2024

Primary Completion (Estimated)

June 4, 2025

Study Completion (Estimated)

June 4, 2025

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-24-0384
  • 5K76AG059931-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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