Effect of "Coping With Stress Program" to Depression and Anxiety Symptoms and Brain Functions in Adolescent at High-Risk for Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- 20 of participants' change from baseline brain functions at 2 months assessed by functional Magnetic Resonans Imaging
研究概览
简要总结
Depression is one of the leading diseases that cause disability, disease burden and threaten public health all over the world. In addition to the economic burdens brought on by depression, it also leads to many individual problems such as deterioration in education, increased psychiatric illnesses in the future, self-harm and suicide. For these reasons, it is important to prevent depression or delay the onset of depression. One of the depression prevention programs, "Coping with Stress Program", is a psychoeducational group program based on cognitive-behavioral therapy and researches shows that the program reduces the rate of diagnosing depression and depressive symptoms in adolescents. Although it is an important mental health problem, studies on adolescent depression are limited in Turkey and existing studies are descriptive and there are no randomized controlled trials. It is believed that this research will encourage studies to prevent depression in Turkey.
The primary aim of this research is to determine the effect of coping with stress program on adolescents' depression and anxiety symptoms, which is applied to adolescents with high risk for depression. The second aim is to examine the changes in brain functions of adolescents participating in the coping with stress program. In the first step, high school students will be screened for depression and adolescents with high levels of depression will be identified. In the second step, randomized controlled experimental design will be used. At the first stage of the study, adolescents with high levels of depression and volunteering to participate in the study will be randomly assigned to the experimental and control groups. After pre-test measurements (determination of depression and anxiety level, functional magnetic resonance imaging (fMRI)), the Coping with Stress Program will be applied to the adolescents in the experimental group. Post-test measures (determination of depression and anxiety level, fMRI) will be performed. The amygdala stimulation test will be used for the fMRI experiment and the data obtained from the fMRI before and after the program will be investigated using the general linear model with Statistical Parametric Mapping (SPM).
详细描述
Study Type: The study was designed as a randomized controlled trial. Site and Date of the Study: The study will be conducted between October 2018 and January 2020 with the first-year high school students who are registered in the high schools under the governance of Izmir Balcova District National Education Directorate.
Participants: The calculation of the sampling size was based on the Brain Functions outcome. It was recommended that at least 20 subjects should be included in each group for brain imaging studies. Taking into consideration the parametric characteristics of the data, which will be obtained with the scale, the investigators planned to include a total of 60 subjects (30 subjects in each group) in the study. The investigators also planned that 6-10 subjects should be adolescents in each group in experimental group. Experimental group will be evaluated with the help of the Coping with Stress Program.
The sampling process of the study: During the initial phase of the study, adolescents, who will score 19 or more in the Children's Depression Scale, will be determined. The adolescents, who will fulfill the inclusion criteria, will be evaluated by the investigator with the help of the Hamilton Depression Scale. Adolescents, who will have a score equal to or more than 29 will be referred by the investigator to the Outpatient Department of the Children/Adolescent Mental Health at Dokuz Eylül University.
The adolescents, who will fulfill the inclusion criteria, will be informed about the study's objective and methodology during a face-to-face conversation and their families will be informed by phone. The consent form will be handed to the adolescents in order that participants forward it to the parents for signing if they approve the participation of their children in the study. The adolescents, who will accept to participate, will be numbered starting from 1 and they will be randomized in the experimental and control groups with the help of a simple table of randomized numbers (experimental group: 30 subjects; control group: 30 subjects).
In the school, the subjects will undergo pre-test evaluation with Children Depression Scale, The Center for Epidemiological Studies Depression Scale, and Beck's Anxiety Scale after the obtainment of their verbal and written consent. Then 20 adolescents from the experimental group and 20 healthy adolescents will undergo fMRI examination. The individual characteristics of the groups (age, gender, socio-economic status, history of depression in parents) will be compared regarding the significant differences.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being first-grader high school student
- •Being volunteer for participation in the study
- •Obtaining the consent of parents' adolescent
- •Being literate
- •Fluent speaking and understanding of Turkish language
- •Scores equal to or higher than 19 in the Children Depression Scale
排除标准
- •Previously diagnosed with depression
- •Previously diagnosed with a psychiatric disease
- •Presence of a diagnosis of bipolar I or schizophrenia in parents
- •Usage of psychotropic agents
- •Previous participation in a cognitive-behavioral therapy (more than 8 sessions)
- •Previous head trauma (with a conscious loss more than 3 minutes)
- •Any reason preventing the participant to enter the MRI device (pacemaker, prosthesis, claustrophobia, etc.).
- •Scores equal to or higher than 29 in the Hamilton Depression Rating Scale.
- •Presence of a chronic physical disease
结局指标
主要结局
20 of participants' change from baseline brain functions at 2 months assessed by functional Magnetic Resonans Imaging
时间窗: Data will be collected before the program starts (pretest) and two months after the end of the program
Functional magnetic resonance imaging measures brain activity by detecting changes associated with blood flow. The amygdala stimulation test will be used for the functional magnetic resonance imaging experiment and the data obtained from the fMRI analysis with Statistical Parametric Mapping (SPM). Functional Magnetic resonance imaging of the participants will be performed with Siemens 3 Tesla MRI device.
次要结局
- Change from baseline depressive symptoms at 3, 6 and 12 months assessed by Center of Epidemiological Studies Depression Scale(Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program)
- Change from baseline depressive symptoms at 3, 6 and 12 months assessed by Children Depression Inventory(Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program)
- Change from baseline anxiety symptoms at 3, 6 and 12 months assessed by Beck Anxiety Inventory(Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program)
研究者
Burcu Özkul
Research Assistant
Dokuz Eylul University