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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
Sponsor:
Information provided by (Responsible Party):
Burcu Özkul, Dokuz Eylul University

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).


Condition or disease Intervention/treatment Phase
Depression Behavioral: Coping with Stress Course Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   14 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Neslihan Günüşen, PhD 90 232 - 4124781 neslihan.gunusen@gmail.com
Contact: Burcu Özkul, MsC 90 232 412 47 79 aksoyyb@gmail.com

Locations
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Turkey
Dokuz Eylul University Recruiting
İzmir, Balçova, Turkey, 35340
Contact: Neslihan Günüşen, PhD    90 232 - 4124781    neslihan.gunusen@gmail.com   
Contact: Burcu Özkul, MsC    90 232 - 4124779    aksoyyb@gmail.com   
Sponsors and Collaborators
Dokuz Eylul University

Publications:
Schmaal L, Veltman DJ, van Erp TG, Sämann PG, Frodl T, Jahanshad N, Loehrer E, Tiemeier H, Hofman A, Niessen WJ, Vernooij MW, Ikram MA, Wittfeld K, Grabe HJ, Block A, Hegenscheid K, Völzke H, Hoehn D, Czisch M, Lagopoulos J, Hatton SN, Hickie IB, Goya-Maldonado R, Krämer B, Gruber O, Couvy-Duchesne B, Rentería ME, Strike LT, Mills NT, de Zubicaray GI, McMahon KL, Medland SE, Martin NG, Gillespie NA, Wright MJ, Hall GB, MacQueen GM, Frey EM, Carballedo A, van Velzen LS, van Tol MJ, van der Wee NJ, Veer IM, Walter H, Schnell K, Schramm E, Normann C, Schoepf D, Konrad C, Zurowski B, Nickson T, McIntosh AM, Papmeyer M, Whalley HC, Sussmann JE, Godlewska BR, Cowen PJ, Fischer FH, Rose M, Penninx BW, Thompson PM, Hibar DP. Subcortical brain alterations in major depressive disorder: findings from the ENIGMA Major Depressive Disorder working group. Mol Psychiatry. 2016 Jun;21(6):806-12. doi: 10.1038/mp.2015.69. Epub 2015 Jun 30.

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Responsible Party: Burcu Özkul, Research Assistant, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT03779477     History of Changes
Other Study ID Numbers: 453594
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Burcu Özkul, Dokuz Eylul University:
Depression
High-Risk
Adolescent
fMRI
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders