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

NCT03779477 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2021-02-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Dokuz Eylul University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-05
Primary Completion
2020-02-03
Completion
2020-02-15

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03779477 on ClinicalTrials.gov