PST in Surgery: Feasibility and Acceptability Pilot

Study Overview
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Brief Summary
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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?

Detailed Description
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We will conduct a pilot test of a 9 session psychosocial intervention (Problem Solving Treatment, PST) at the University of Texas, Southwestern Medical Center (UTSW). We will recruit 90 older surgical patients 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. This study will provide preliminary data to inform an R01 submission assessing the impact of PST on post-operative functional recovery. Summary of Objectives. Examine the feasibility of implementing an evidence based psychosocial intervention, PST, for older surgical patients with depressive symptoms. Demonstrate the acceptability of the intervention delivery for older surgical patients with depressive symptoms. Evaluate the potential improvement in function and reduction in depressive symptoms. Setting: We will be recruiting 90 older adults at the UTSW POSH clinic who are undergoing major surgery in 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 by two pathways - clinician referral and self-referral. (1) Clinician referral: clinicians refer via recruitment flyer, by clinic team at clinic visit or via email to study team. (2) Self-referral: recruitment flyers utilized in waiting rooms and clinical offices for interested patients to contact the study team. Clinician referral details: Clinicians will send the research team the patient's name and phone number for recruitment if they believe the patient is experiencing depressive symptoms. The study team will reach out to the patient to recruit them into the study. Enrollment and consent forms will be sent for e-consent with RedCAP or DocuSign or with a paper document sent to the patient with a pre-paid envelope with a return address. Training of interventionists: Interventionists will be trained with a problem solving therapy master trainer. We will recruit participants for this training until all interventionists meet criteria for intervention delivery. See practicing participant consent form.

Official Title
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Building Psychosocial Resilience in Older Adults Facing Major Surgery: Feasibility and Acceptability Pilot Study

Conditions
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Psychosocial Functioning, Surgery, Older Adults, Physical Function, Postoperative Outcome, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Problem Solving Therapy (PST)


Participation Criteria
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Eligibility Criteria
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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 - PHQ-9 screening with a score of 6+, 6-9 being subclinical depression. 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. Interventionists will be trained by Dr. Tang. They will receive a manual, which includes a sample script, and materials adapted based on findings from our qualitative study with patients and caregivers. Dr. Tang will ensure fidelity of the intervention once a month by observing one of the sessions, per interventionist. 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. | Behavioral: Problem Solving Therapy (PST)<br>* 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.<br>|
| No Intervention: Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Recovery | 6-month functional recovery as measured by a comparison of the pre- and post-operative function using self-report to the WHODAS. Our 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 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive Symptoms | Our secondary outcome is 3 and 6-month depressive symptoms, as measured by PHQ-9. Baseline, intermediate, outcome measures and feasibility and acceptability measures will be collected. | 3 months after surgery and 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosocial Functioning, Surgery, Older Adults, Physical Function, Postoperative Outcome, Depressive Symptoms