Depression Clinical Trial
Official title:
Effect of "Coping With Stress Program" to Depression and Anxiety Symptoms and Brain Functions in Adolescent at High-Risk for Depression
Verified date | February 2021 |
Source | Dokuz Eylul University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 57 |
Est. completion date | February 15, 2020 |
Est. primary completion date | February 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 15 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. - Plow - Presence of a chronic physical disease |
Country | Name | City | State |
---|---|---|---|
Turkey | Dokuz Eylul University | Izmir | Balçova |
Lead Sponsor | Collaborator |
---|---|
Dokuz Eylul University |
Turkey,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 20 of participants' change from baseline brain functions at 2 months assessed by functional Magnetic Resonans Imaging | 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. | Data will be collected before the program starts (pretest) and two months after the end of the program | |
Secondary | Change from baseline depressive symptoms at 3, 6 and 12 months assessed by Children Depression Inventory | Data will be collected by the Children Depression Inventory. 0-54 points can be taken from the Children Depression Inventory. The higher the score indicates the greater the severity of depression.The cutpoint of the scale is 19 points. | Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program | |
Secondary | Change from baseline depressive symptoms at 3, 6 and 12 months assessed by Center of Epidemiological Studies Depression Scale | Data will be collected by the Center of Epidemiological Studies Depression Scale. 0 to 60 points can be obtained from the Center for Epidemiological Studies Depression Scale and the higher the score indicates the more depressive symptoms. | Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program | |
Secondary | Change from baseline anxiety symptoms at 3, 6 and 12 months assessed by Beck Anxiety Inventory | Data will be collected by the Beck Anxiety Inventory. The total score ranges from 0 to 63. As the total scores of the scale increase, the level of anxiety of the person increases. | Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program |
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