Effect of Physiotherapy Protocol in Treatment of Depression: Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Assessing the change in severity of respondents' depression
研究概览
简要总结
The purpose of his study is to investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.
详细描述
This study will investigate the effect of physiotherapy protocol in management of depression in patients with fibromyalgia and in patients with psychogenic depression.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fibromyalgia patients will be included if they meet the diagnosis of FM according to the American College Rheumatology (ACR), diagnosed with depression and referred by a physician.
- •Patients diagnosed with mild and moderate forms of major depression.
- •Their ages range from 20- 60 years old.
- •Patients willing and able to participate in a physiotherapy program and capable of doing physical exercise on their own.
排除标准
- •severe spinal injuries
- •severe musculoskeletal abnormalities
- •inflammatory rheumatic diseases
- •respiratory or cardiac pathologies
- •Any vestibular, visual or neurological dysfunction affecting balance.
- •History of suicidal attempts
- •Severe depression
- •Suffering from severe somatic or psychiatric disorders.
研究组 & 干预措施
Patients with fibromyalgia and depression (1)
Patients in this group will receive physiotherapy protocol and medications.
干预措施: Physiotherapy protocol (Other)
Patients with fibromyalgia and depression (1)
Patients in this group will receive physiotherapy protocol and medications.
干预措施: Selective serotonin reuptake inhibitors (SSRI) (Drug)
Patients with fibromyalgia and depression (2)
Patients in this group will receive medications only.
干预措施: Selective serotonin reuptake inhibitors (SSRI) (Drug)
Patients with depression only (1)
Patients in this group will receive physiotherapy protocol and medications.
干预措施: Physiotherapy protocol (Other)
Patients with depression only (1)
Patients in this group will receive physiotherapy protocol and medications.
干预措施: Selective serotonin reuptake inhibitors (SSRI) (Drug)
Patients with depression only (2)
Patients in this group will receive medications only.
干预措施: Selective serotonin reuptake inhibitors (SSRI) (Drug)
结局指标
主要结局
Assessing the change in severity of respondents' depression
时间窗: at baseline, after 2 weeks of intervention, after 4 weeks of intervention and after one month and two months of end of treatment period
Assessment will be done by using Arabic version of Beck Depression Inventory (BDI) which is designed to rate the severity of respondents' depression in the weeks preceding questionnaire completion. Each of the 21 questions presents four different statements and asks respondents to select the option that best represents them. Statements refer to depressive states in varying degrees of severity (from "I do not feel sad" to "I am so sad or unhappy that I can't stand it"), and this is reflected in the scoring process which assigns higher values to responses indicating more acute symptoms of depression. The total score can range from 0 to 63 points, with a total score of 0-9 points indicating minimal depression, 10-18 points mild, 19-29 points moderate, and 30-63 points severe depression.
次要结局
未报告次要终点
研究者
Mahitab Momen Gamal-Eldien Elansary
Principal Investigator
Cairo University