Ignite Creation Date:
2024-05-06 @ 12:30 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03779477
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2018-12-06
Brief Title:
Effect of Coping With Stress Program to Depression Anxiety Brain Functions in Adolescent at High-Risk for Depression
Sponsor:
Dokuz Eylul University
Organization:
Dokuz Eylul University
Study Overview
Official Title:
Effect of Coping With Stress Program to Depression and Anxiety Symptoms and Brain Functions in Adolescent at High-Risk for Depression
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 Childrens 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 ChildrenAdolescent Mental Health at Dokuz Eylül University
The adolescents who will fulfill the inclusion criteria will be informed about the studys 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 Becks 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
Instruments At this phase of the study the investigators plan to use the following forms scales and examinations Information Questionnaire Children Depression Scale The Center for Epidemiological Studies Depression Scale Becks Anxiety Scale Hamilton Depression Rating Scale 3 Tesla Magnetic Resonance Imaging Device and Functional Magnetic Resonance Imaging fMRI
Magnetic Resonance Imaging MRI Technique The MRI examinations will be conducted with 30 Tesla magnet Siemens Erlangen Germany using a 12-channel head coil First the investigators will obtain structural images with the axial turbo spin echo TSE T2-weighted coronary 3D-SPACE FLAIR Dark fluid and 3D-MPRAGE sequences The obtained images will be immediately examined by the radiologist and interpreted for the presence of a brain anomalypathology considered among the inclusion criteria Subjects without any radio-pathological finding will also be referred to the fMRI examination The blood oxygen level-dependent BOLD technique which is previously designed in concordance with the task design will be used for the fMRI
fMRI Task Meta-analyses which are focused on the evaluation of the structural and functional MRI studies of the depression patients demonstrated anomalies in the amygdala hippocampus and subcortical regions Therefore the investigators decided to use an fMRI task which will stimulate these structures The amygdala stimulation test developed by Hariri Bookheimer Mazziotta is widely used in the studies and it was demonstrated that it could strongly and consistently stimulate amygdala
This test will be performed in a single session and the subjects will be asked to fulfill two different tasks The first task consists of 3 blocks of cognitive face processing task and the second task consists of 4 blocks of sensorimotor control task Facial expressions of anger fear surprise and neutral faces from the FACES stimulus set will be used for this purpose with equal numbers of male and female faces Face-matching blocks will exhibit three faces with one on the top and two at the bottom The expressions will consist of anger fear surprise and neutral outlook The participant will be asked to match the face on the top with one of the faces at the bottom which heshe will consider having the same expression For each face expression eg fear there will be 6 trials which are equalized for the gender distribution Each test will last 6 seconds There will be an interval of 3 seconds between each test inter-stimulus interval Each block lasts 54 seconds In the sensorimotor control blocks the participant will have 3 geometric shapes circle horizontal and vertical ellipses one on the top and two at the bottom and will be asked to match the shape on the top with one at the bottom which heshe will consider as same Each control block contains 6 different shapes matching and each test lasts 6 seconds There will be a 3-second inter-stimulus interval between each test Each block lasts 54 seconds The blocks will start after a short instruction match the shapes or match the faces The total duration of the fMRI task is 399 seconds Responses and the response time will be recorded
Data Collection Implementation 9th grader high school students will be screened during the 2018-2019 school year and the Coping with Stress Program will be implemented in the experimental group which will consist of 30 students The demographic data of each student in the experimental and control groups will be collected with a data collection questionnaire before the start of the study pre-test measurements
After the pre-test measurements 20 volunteers from the control group will be scheduled for the fMRI examination The adolescents and their family will be instructed about the measures which are to be considered at the examination day and the adolescents will be informed that heshe should not fasten before the examination On the examination day the adolescents will be interviewed in the room of the Standardization of Computational Anatomy Techniques fıor Cognitive and Behavioral Sciences SoCAT research group in the Ege University Department of Mental Health and Psychiatry During the interview the adolescents will receive instructions about the fMRI task During this instruction which will last approx 15 minutes a facial expression set a shorter version of the set used during the fMRI examination will be implemented The adolescents who have completed the instruction will be referred to the 3 Tesla MRI unit of the Radiology Department in Ege University and will undergo MRI examination The fMRI examination will be performed between 1000-1400 in weekends as the unit is overloaded in weekdays The adolescents will be asked not to move in the MRI device and will be informed that the fMRI process will start just after the structural imaging is completed The structural imaging will last approx 5 minutes and will be followed by the fMRI During the whole process the investigator Burcu Özkul and the radiology technician will be present in the MRI unit Healthy adolescents will also undergo fMRI
The subjects in the experimental group will undergo the Coping with Stress Program There will be no intervention in the control group only pre-test final test and monitoring measurements will be performed After the completion of the program implemented in the experimental group final test all measurements will be repeated in the 3rd 6th and 12th months in both experimental and control groups fMRI imaging will be repeated for the subjects in the experimental group in the 2nd month
Data Analysis The data obtained during the study will be analyzed with the Statistical Package for the Social Sciences SPSS v22 software package Demographic data will be expressed with descriptive statistics such as percentage mean and standard deviation The distribution of the continuous data will be analyzed with the Kolmogorov-Smirnov Test and the homogeneity of the groups will be evaluated with Chi-square test Regarding the repeated comparative measurements performed before the start of the program they will be evaluated after the instruction in the 3rd 6th and 12th months with the variance analysis
fMRI Analysis The images in DICOM format will be uploaded in the SPM 12 software and the standard pre-processing will be carried out This process constitutes of a re-alignment process aligning of the images in the time sequence in a 3D format the normalization to the standard space MNI and finally the smoothing process A general linear model GLM will be used for the statistical analysis Therefore the common and different neural circuits between the groups will be determined The p-value of 005 will be considered as statistically significant for the intergroup comparisons after the correction according to the multiple comparisons with the family-wise error correction The minimum cluster threshold will be limited to 5 voxels
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 Childrens 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 ChildrenAdolescent Mental Health at Dokuz Eylül University
The adolescents who will fulfill the inclusion criteria will be informed about the studys 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 Becks 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
Instruments At this phase of the study the investigators plan to use the following forms scales and examinations Information Questionnaire Children Depression Scale The Center for Epidemiological Studies Depression Scale Becks Anxiety Scale Hamilton Depression Rating Scale 3 Tesla Magnetic Resonance Imaging Device and Functional Magnetic Resonance Imaging fMRI
Magnetic Resonance Imaging MRI Technique The MRI examinations will be conducted with 30 Tesla magnet Siemens Erlangen Germany using a 12-channel head coil First the investigators will obtain structural images with the axial turbo spin echo TSE T2-weighted coronary 3D-SPACE FLAIR Dark fluid and 3D-MPRAGE sequences The obtained images will be immediately examined by the radiologist and interpreted for the presence of a brain anomalypathology considered among the inclusion criteria Subjects without any radio-pathological finding will also be referred to the fMRI examination The blood oxygen level-dependent BOLD technique which is previously designed in concordance with the task design will be used for the fMRI
fMRI Task Meta-analyses which are focused on the evaluation of the structural and functional MRI studies of the depression patients demonstrated anomalies in the amygdala hippocampus and subcortical regions Therefore the investigators decided to use an fMRI task which will stimulate these structures The amygdala stimulation test developed by Hariri Bookheimer Mazziotta is widely used in the studies and it was demonstrated that it could strongly and consistently stimulate amygdala
This test will be performed in a single session and the subjects will be asked to fulfill two different tasks The first task consists of 3 blocks of cognitive face processing task and the second task consists of 4 blocks of sensorimotor control task Facial expressions of anger fear surprise and neutral faces from the FACES stimulus set will be used for this purpose with equal numbers of male and female faces Face-matching blocks will exhibit three faces with one on the top and two at the bottom The expressions will consist of anger fear surprise and neutral outlook The participant will be asked to match the face on the top with one of the faces at the bottom which heshe will consider having the same expression For each face expression eg fear there will be 6 trials which are equalized for the gender distribution Each test will last 6 seconds There will be an interval of 3 seconds between each test inter-stimulus interval Each block lasts 54 seconds In the sensorimotor control blocks the participant will have 3 geometric shapes circle horizontal and vertical ellipses one on the top and two at the bottom and will be asked to match the shape on the top with one at the bottom which heshe will consider as same Each control block contains 6 different shapes matching and each test lasts 6 seconds There will be a 3-second inter-stimulus interval between each test Each block lasts 54 seconds The blocks will start after a short instruction match the shapes or match the faces The total duration of the fMRI task is 399 seconds Responses and the response time will be recorded
Data Collection Implementation 9th grader high school students will be screened during the 2018-2019 school year and the Coping with Stress Program will be implemented in the experimental group which will consist of 30 students The demographic data of each student in the experimental and control groups will be collected with a data collection questionnaire before the start of the study pre-test measurements
After the pre-test measurements 20 volunteers from the control group will be scheduled for the fMRI examination The adolescents and their family will be instructed about the measures which are to be considered at the examination day and the adolescents will be informed that heshe should not fasten before the examination On the examination day the adolescents will be interviewed in the room of the Standardization of Computational Anatomy Techniques fıor Cognitive and Behavioral Sciences SoCAT research group in the Ege University Department of Mental Health and Psychiatry During the interview the adolescents will receive instructions about the fMRI task During this instruction which will last approx 15 minutes a facial expression set a shorter version of the set used during the fMRI examination will be implemented The adolescents who have completed the instruction will be referred to the 3 Tesla MRI unit of the Radiology Department in Ege University and will undergo MRI examination The fMRI examination will be performed between 1000-1400 in weekends as the unit is overloaded in weekdays The adolescents will be asked not to move in the MRI device and will be informed that the fMRI process will start just after the structural imaging is completed The structural imaging will last approx 5 minutes and will be followed by the fMRI During the whole process the investigator Burcu Özkul and the radiology technician will be present in the MRI unit Healthy adolescents will also undergo fMRI
The subjects in the experimental group will undergo the Coping with Stress Program There will be no intervention in the control group only pre-test final test and monitoring measurements will be performed After the completion of the program implemented in the experimental group final test all measurements will be repeated in the 3rd 6th and 12th months in both experimental and control groups fMRI imaging will be repeated for the subjects in the experimental group in the 2nd month
Data Analysis The data obtained during the study will be analyzed with the Statistical Package for the Social Sciences SPSS v22 software package Demographic data will be expressed with descriptive statistics such as percentage mean and standard deviation The distribution of the continuous data will be analyzed with the Kolmogorov-Smirnov Test and the homogeneity of the groups will be evaluated with Chi-square test Regarding the repeated comparative measurements performed before the start of the program they will be evaluated after the instruction in the 3rd 6th and 12th months with the variance analysis
fMRI Analysis The images in DICOM format will be uploaded in the SPM 12 software and the standard pre-processing will be carried out This process constitutes of a re-alignment process aligning of the images in the time sequence in a 3D format the normalization to the standard space MNI and finally the smoothing process A general linear model GLM will be used for the statistical analysis Therefore the common and different neural circuits between the groups will be determined The p-value of 005 will be considered as statistically significant for the intergroup comparisons after the correction according to the multiple comparisons with the family-wise error correction The minimum cluster threshold will be limited to 5 voxels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None