Effect of Coping With Stress Program to Depression, Anxiety, Brain Functions in Adolescent at High-Risk for Depression

NCT03779477 | Completed

• 1 other identifier: 453594
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression

Keywords

Depression; High-Risk; Adolescent; fMRI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 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 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

Study Arms (2)

Coping with Stress Course

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Coping with Stress Course BEHAVIORAL

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.

Coping with Stress Course

Eligibility Criteria

• Age: 14 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

Related Publications (7)

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  PMID: 22641837 BACKGROUND

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  PMID: 22006061 BACKGROUND

• Foland-Ross LC, Hardin MG, Gotlib IH. Neurobiological markers of familial risk for depression. Curr Top Behav Neurosci. 2013;14:181-206. doi: 10.1007/7854_2012_213.

  PMID: 22573472 BACKGROUND

• Murray EA, Wise SP, Drevets WC. Localization of dysfunction in major depressive disorder: prefrontal cortex and amygdala. Biol Psychiatry. 2011 Jun 15;69(12):e43-54. doi: 10.1016/j.biopsych.2010.09.041. Epub 2010 Dec 15.

  PMID: 21111403 BACKGROUND

• Schmaal L, Veltman DJ, van Erp TG, Samann 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, Volzke H, Hoehn D, Czisch M, Lagopoulos J, Hatton SN, Hickie IB, Goya-Maldonado R, Kramer B, Gruber O, Couvy-Duchesne B, Renteria 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.

  PMID: 26122586 BACKGROUND

• Hariri AR, Bookheimer SY, Mazziotta JC. Modulating emotional responses: effects of a neocortical network on the limbic system. Neuroreport. 2000 Jan 17;11(1):43-8. doi: 10.1097/00001756-200001170-00009.

  PMID: 10683827 BACKGROUND

• Baranger DAA, Margolis S, Hariri AR, Bogdan R. An earlier time of scan is associated with greater threat-related amygdala reactivity. Soc Cogn Affect Neurosci. 2017 Aug 1;12(8):1272-1283. doi: 10.1093/scan/nsx057.

  PMID: 28379578 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 19, 2018
• Study Start: November 5, 2018
• Primary Completion: February 3, 2020
• Study Completion: February 15, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Locations

TU (1)