Can Fluoxetine Mitigate the Mental Health Decline Seen in Patients With Musculoskeletal Trauma?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Serial mental well-being surveys in the post-injury period for patients with musculoskeletal trauma.
研究概览
简要总结
Musculoskeletal trauma is one of the leading causes of disability in the United States and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues following their injury. These symptoms can develop across all spectrums of patients with a variety of injury severities. Previously, this research team developed a ten-step program with the aim of developing fostering coping mechanisms in trauma patients. We were unable to demonstrate a measurable benefit to their mental health or physical function. This has been mirrored in other studies as well; talk therapy and support groups are not a strong enough intervention for some patients.
We hypothesize that a subset of the trauma population would benefit from medical treatment for their depressive and anxious symptoms in the early recovery period. Given the limited resources of mental health systems, it would be ideal for their surgical providers to be able to manage safely their post-injury mental health issues during their surgical follow up. This is a pragmatic pilot study to develop an effective, acceptable, time-limited treatment strategy that could be safely implemented by non-mental health care providers for victims of musculoskeletal trauma.
详细描述
Rationale
Over 50% of victims of musculoskeletal trauma suffer prolonged depressive and anxious symptomology following their initial injury. This is an independent risk factor for prolonged mental and physical disability. In previous research by the study team in orthopedic trauma patients without previous diagnosis of psychiatric illness, we have demonstrated 28% of these patients had depressive symptomology and 40% had anxiety symptomology 3 months following their traumatic injury. [1] Mental health resources are limited, placing the bulk of patient care on the orthopedic surgeons and primary care physicians. Support groups, self-help programs and talk therapy, while valuable, have not demonstrated measurable efficacy for this patient population. We hypothesize that a subset of the trauma population would benefit from medical treatment for their depressive and anxious symptoms in the early recovery period.
Specific Aims
Aim 1: Evaluate the efficacy of immediate Fluoxetine therapy versus standard of care Calcium treatment in improving mental health and wellbeing in the post-injury period for patients with musculoskeletal trauma.
Hypothesis: Patients randomized to Fluoxetine will have less severe depression, anxiety and post-traumatic stress symptoms than those treated with calcium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Researchers collecting survey data will be blinded to patients' intervention status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 18 and older under the care of the UF Orthopedic Trauma Division admitted to UF Health for trauma resulting in one or more extremity or pelvic fractures requiring surgery will be screened.
排除标准
- •patients with Traumatic Brain Injury or a past medical history of bipolar or other mental health conditions on current medical management will be excluded
- •patients unlikely to follow up (live in at a distance from Gainesville, incarcerated etc.) will also be excluded.
研究组 & 干预措施
Subjects randomized to get Fluoxetine therapy
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
干预措施: Fluoxetine (Drug)
Subjects randomized to get Calcium Supplmentation
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
干预措施: Calcium (Drug)
结局指标
主要结局
Serial mental well-being surveys in the post-injury period for patients with musculoskeletal trauma.
时间窗: Baseline up to 12 months
BDI-II - Beck Depression Inventory-II
时间窗: Baseline, 2 weeks, 6 weeks,3 months, 6 months, 1 year
Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of depressive symptoms.
BAI - Beck Anxiety Inventory
时间窗: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of anxiety symptoms.
PSQI - Pittsburgh Sleep Quality Index
时间窗: 2 weeks, 6 weeks, 3 months
Score range 0-21. Higher scores indicate worse outcomes, representing poorer sleep quality.
PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5
时间窗: Baseline, 2 weeks, 6 weeks, 6 months, 1 year
Score range 0-80. Higher scores indicate worse outcomes, representing greater PTSD symptom severity.
PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System
时间窗: 6 weeks, 3 months,6 months, 1 year
Scores are typically reported as T-scores, which generally range from about 20-80 (population mean = 50, standard deviation = 10). Higher scores indicate worse outcomes, meaning greater perceived social isolation, a higher PROMIS Social Isolation score reflects feeling more isolated, excluded, or disconnected from others, while lower scores indicate better social connectedness and less isolation.
次要结局
- Patient reported pain scores (PEG score) will be recorded at each visit.(Baseline up to 12 months)
- PEG - Pain, Enjoyment of Life, and General Activity Scale(Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year)