Building Resilience for Surgical Recovery

NCT06174701 | Recruiting DMC

• 2 other identifiers: HSC-MS-24-03845K76AG059931-05
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 pre-operative and post-operative setting?

Conditions

Psychosocial Functioning; Surgery; Older Adults; Physical Function; Postoperative Outcome; Depressive Symptoms

Keywords

Psychosocial Functioning; Surgery; Older Adults; Physical Function; Postoperative Outcome; Depressive Symptoms

Outcome Measures

Primary Outcomes (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.

  6 months after baseline

Secondary Outcomes (1)

• Depressive Symptoms as Assessed by Score on the by the Patient Health Questionnaire (PHQ-9)

  3 months and 6 months after baseline

Other Outcomes (7)

• Physical pain

  Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.

• Cognition

  Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.

• Depressive symptoms

  Day of enrollment (baseline), 1 month after baseline, 3 months after baseline and 6 months after baseline.

Study Arms (2)

Problem Solving Therapy (PST)

EXPERIMENTAL

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)

Enhanced Usual Care

EXPERIMENTAL

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

Interventions

Problem Solving Therapy (PST) BEHAVIORAL

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.

Problem Solving Therapy (PST)

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Aging (NIA): collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Related Publications (20)

• 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.

  PMID: 20510798 BACKGROUND

• 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.

  PMID: 7732159 BACKGROUND

• 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.

  PMID: 14627256 BACKGROUND

• 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.

  PMID: 19093915 BACKGROUND

• 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.

  PMID: 29054389 BACKGROUND

• 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.

  PMID: 11685203 BACKGROUND

• 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.

  PMID: 28424140 BACKGROUND

• 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.

  PMID: 25844523 BACKGROUND

• 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.

  PMID: 27295578 BACKGROUND

• 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.

  PMID: 28399883 BACKGROUND

• 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.

  PMID: 27605004 BACKGROUND

• 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.

  PMID: 26643299 BACKGROUND

• 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.

  PMID: 2789747 BACKGROUND

• 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.

  PMID: 30289968 BACKGROUND

• 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.

  PMID: 14044222 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• Lawrence VA, Hazuda HP, Cornell JE, Pederson T, Bradshaw PT, Mulrow CD, Page CP. Functional independence after major abdominal surgery in the elderly. J Am Coll Surg. 2004 Nov;199(5):762-72. doi: 10.1016/j.jamcollsurg.2004.05.280.

  PMID: 15501119 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

• Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to guide power calculations for study proposals. Arch Gen Psychiatry. 2006 May;63(5):484-9. doi: 10.1001/archpsyc.63.5.484.

  PMID: 16651505 BACKGROUND

• Tang V, Pepic L, Higuchi E, Keny C, Macias Lopez E, Onyema EC, Sandhu H, Yank V, Raue PJ. Implementing PST in older adults facing major surgery: a randomised controlled pilot study. BMJ Open. 2025 Nov 12;15(11):e103605. doi: 10.1136/bmjopen-2025-103605.

  PMID: 41224294 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Victoria Tang, MD, MAS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jude des Bordes, MBChB, MPH, DrPH, CPH

CONTACT

713-500-4434; Jude.K.desBordes@uth.tmc.edu

Victoria Tang, MD, MAS

CONTACT

713-500-6104; Victoria.Tang@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The data collectors on the study team will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: June 4, 2024
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)