Effect of Coping With Stress Program to Depression, Anxiety, Brain Functions in Adolescent at High-Risk for Depression
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|ClinicalTrials.gov Identifier: NCT03779477|
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : December 18, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Coping with Stress Course||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of "Coping With Stress Program" to Depression and Anxiety Symptoms and Brain Functions in Adolescent at High-Risk for Depression|
|Actual Study Start Date :||November 5, 2018|
|Estimated Primary Completion Date :||March 1, 2019|
|Estimated Study Completion Date :||January 15, 2020|
Experimental: Coping with Stress Course
The Coping with Stress Program that consists of 8 sessions will be implemented to the experimental group. 8-10 adolescents will be included in this program. The session frequency will be one session per week. After the completion of 8 sessions, two 90-minute sessions will be carried out each month in the following two months.
Behavioral: Coping with Stress Course
The Coping with Stress Program is a group program, which is developed by Clarke and Lewinson (1995) for the prevention of depression in high-risk adolescents. It is based on cognitive-behavioral therapy principles and contains psychoeducation and cognitive-behavioral therapy interventions. There are handbooks available for the group leader of the program and the participating adolescents. In the handbook developed for the group leader, there is detailed information about the objective of each session and the implemented interventions. The adolescents will find lists organized for the fulfillment of the tasks in the handbook prepared for them. The handbooks of the program were translated in Turkish and experts were consulted for their validity.
No Intervention: Control
There will be no intervention in the control group. If the program will be effective, this group will also undergo the Coping with Stress Program after the termination of the study.
- 20 of participants' change from baseline brain functions at 2 months assessed by functional Magnetic Resonans Imaging [ Time Frame: 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.
- Change from baseline depressive symptoms at 3, 6 and 12 months assessed by Children Depression Inventory [ Time Frame: Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program ]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.
- Change from baseline depressive symptoms at 3, 6 and 12 months assessed by Center of Epidemiological Studies Depression Scale [ Time Frame: Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program ]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.
- Change from baseline anxiety symptoms at 3, 6 and 12 months assessed by Beck Anxiety Inventory [ Time Frame: Data will be collected before the program starts (pretest), three months,six months and one-year after the end of the program ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779477
|Contact: Neslihan Günüşen, PhD||90 232 - firstname.lastname@example.org|
|Contact: Burcu Özkul, MsC||90 232 412 47 email@example.com|
|Dokuz Eylul University||Recruiting|
|İzmir, Balçova, Turkey, 35340|
|Contact: Neslihan Günüşen, PhD 90 232 - 4124781 firstname.lastname@example.org|
|Contact: Burcu Özkul, MsC 90 232 - 4124779 email@example.com|