Building Resilience for Surgical Recovery: Feasibility and Acceptability Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)
研究概览
简要总结
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?
详细描述
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:
- 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:
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The data collectors on the study team will be masked.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Problem Solving Therapy (PST) (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.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Functional Recovery as Assessed by Score on the World Health Organization Disability Assessment Schedule (Brief-WHODAS)
时间窗: 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.
次要结局
- Depressive Symptoms as Assessed by Score on the by the Patient Health Questionnaire (PHQ-9)(3 months and 6 months after baseline)
研究者
Victoria Tang
Associate Professor
The University of Texas Health Science Center, Houston