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Psychosocial FunctioningBRSRNCT06174701

Building Resilience for Surgical Recovery

A study testing Problem Solving Therapy (PST) in people with Psychosocial Functioning and Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Psychosocial Functioning, Surgery, Older Adults
What is being tested?
Problem Solving Therapy (PST)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteUnited States
Study dates
4 Jun 2024to 30 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • ≥ 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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?

Read the 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.

Being tested
Problem Solving Therapy (PST), Enhanced Usual Care
Keywords
Psychosocial Functioning, Surgery, Older Adults, Physical Function, Postoperative Outcome, Depressive Symptoms
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem Solving Therapy (PST)Behavioural

    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.

  • Enhanced Usual CareBehavioural

    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.

Study groups in NCT06174701
Study groupRoleWhat they receive
Problem Solving Therapy (PST)ExperimentalParticipants 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.
Receives: Behavioral: Problem Solving Therapy (PST)
Enhanced Usual CareExperimentalParticipants 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.
Receives: Behavioral: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)

    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.

    Measured: 6 months after baseline

Secondary outcomes (1)
  1. Depressive Symptoms as Assessed by Score on the by the Patient Health Questionnaire (PHQ-9)

    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.

    Measured: 3 months and 6 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start4 Jun 2024
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06174701
Sponsor's protocol ID
HSC-MS-24-0384
Other IDs
7K76AG059931-06
Acronym
BRSR
Status last verified
Jul 2026
First submitted
8 Dec 2023
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Makary MA, Segev DL, Pronovost PJ, Syin D, Bandeen-Roche K, Patel P, Takenaga R, Devgan L, Holzmueller CG, Tian J, Fried LP. Frailty as a predictor of surgical outcomes in older patients. J Am Coll Surg. 2010 Jun;210(6):901-8. doi: 10.1016/j.jamcollsurg.2010.01.028. Epub 2010 Apr 28.

    PubMed 20510798
  • Oxman TE, Freeman DH Jr, Manheimer ED. Lack of social participation or religious strength and comfort as risk factors for death after cardiac surgery in the elderly. Psychosom Med. 1995 Jan-Feb;57(1):5-15. doi: 10.1097/00006842-199501000-00002.

    PubMed 7732159
  • Etzioni DA, Liu JH, O'Connell JB, Maggard MA, Ko CY. Elderly patients in surgical workloads: a population-based analysis. Am Surg. 2003 Nov;69(11):961-5.

    PubMed 14627256
  • Boyd CM, Landefeld CS, Counsell SR, Palmer RM, Fortinsky RH, Kresevic D, Burant C, Covinsky KE. Recovery of activities of daily living in older adults after hospitalization for acute medical illness. J Am Geriatr Soc. 2008 Dec;56(12):2171-9. doi: 10.1111/j.1532-5415.2008.02023.x.

    PubMed 19093915
  • Berian JR, Zhou L, Hornor MA, Russell MM, Cohen ME, Finlayson E, Ko CY, Robinson TN, Rosenthal RA. Optimizing Surgical Quality Datasets to Care for Older Adults: Lessons from the American College of Surgeons NSQIP Geriatric Surgery Pilot. J Am Coll Surg. 2017 Dec;225(6):702-712.e1. doi: 10.1016/j.jamcollsurg.2017.08.012. Epub 2017 Oct 17.

    PubMed 29054389
  • Finlayson EV, Birkmeyer JD. Outcomes in vascular surgery: volume versus certification. Surgery. 2001 Nov;130(5):897-8. doi: 10.1067/msy.2001.116926. No abstract available.

    PubMed 11685203
  • Kaplan JA, Finlayson E, Auerbach AD. Impact of Multimodality Pain Regimens on Elective Colorectal Surgery Outcomes. Am Surg. 2017 Apr 1;83(4):414-420.

    PubMed 28424140
  • Oresanya L, Zhao S, Gan S, Fries BE, Goodney PP, Covinsky KE, Conte MS, Finlayson E. Functional outcomes after lower extremity revascularization in nursing home residents: a national cohort study. JAMA Intern Med. 2015 Jun;175(6):951-7. doi: 10.1001/jamainternmed.2015.0486.

    PubMed 25844523
  • Cenzer IS, Tang V, Boscardin WJ, Smith AK, Ritchie C, Wallhagen MI, Espaldon R, Covinsky KE. One-Year Mortality After Hip Fracture: Development and Validation of a Prognostic Index. J Am Geriatr Soc. 2016 Sep;64(9):1863-8. doi: 10.1111/jgs.14237. Epub 2016 Jun 13.

    PubMed 27295578
  • Brembo EA, Kapstad H, Van Dulmen S, Eide H. Role of self-efficacy and social support in short-term recovery after total hip replacement: a prospective cohort study. Health Qual Life Outcomes. 2017 Apr 11;15(1):68. doi: 10.1186/s12955-017-0649-1.

    PubMed 28399883
  • Tang VL, Sudore R, Cenzer IS, Boscardin WJ, Smith A, Ritchie C, Wallhagen M, Finlayson E, Petrillo L, Covinsky K. Rates of Recovery to Pre-Fracture Function in Older Persons with Hip Fracture: an Observational Study. J Gen Intern Med. 2017 Feb;32(2):153-158. doi: 10.1007/s11606-016-3848-2. Epub 2016 Sep 7.

    PubMed 27605004
  • Chereau N, Chandeze MM, Tantardini C, Tresallet C, Lefevre JH, Parc Y, Menegaux F. Antroduodenectomy with Gastroduodenal Anastomosis: Salvage Emergency Surgery for Complicated Peptic Ulcer Disease--Results of a Double Institution Study of 35 Patients. J Gastrointest Surg. 2016 Mar;20(3):539-45. doi: 10.1007/s11605-015-3050-6. Epub 2015 Dec 7.

    PubMed 26643299
  • Ryff CD. In the eye of the beholder: views of psychological well-being among middle-aged and older adults. Psychol Aging. 1989 Jun;4(2):195-201. doi: 10.1037//0882-7974.4.2.195.

    PubMed 2789747
  • Kata A, Sudore R, Finlayson E, Broering JM, Ngo S, Tang VL. Increasing Advance Care Planning Using a Surgical Optimization Program for Older Adults. J Am Geriatr Soc. 2018 Oct;66(10):2017-2021. doi: 10.1111/jgs.15554. Epub 2018 Oct 5.

    PubMed 30289968
  • KATZ S, FORD AB, MOSKOWITZ RW, JACKSON BA, JAFFE MW. STUDIES OF ILLNESS IN THE AGED. THE INDEX OF ADL: A STANDARDIZED MEASURE OF BIOLOGICAL AND PSYCHOSOCIAL FUNCTION. JAMA. 1963 Sep 21;185:914-9. doi: 10.1001/jama.1963.03060120024016. No abstract available.

    PubMed 14044222

Questions about this trial

What is this clinical trial studying?

A study testing Problem Solving Therapy (PST) in people with Psychosocial Functioning and Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS) (time frame: 6 months after baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06174701, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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