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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04192721
Other study ID # SDemir
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date February 23, 2018

Study information

Verified date December 2019
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.


Description:

This study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.

The study was completed with a total of 63 participants (n=31 for the intervention group and n=32 for the control group) in the 2017-2018 academic year. The effect of the intervention was evaluated with the Beck Depression Inventory, Beck Anxiety Inventory, Automatic Thoughts Questionnaire, and Ways of Coping Questionnaire. The measurements were taken 3 times: pre-test, post-test, and 2-months post-test.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date February 23, 2018
Est. primary completion date December 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- Having mild depressive symptoms according to the BDI

- Having moderate depressive symptoms according to the BDI

- Being native speakers of Turkish

- Agreeing to participate in the entire intervention process

Exclusion Criteria:

- Having substance abuse

- Having another psychiatric diagnosis

- Using psychotropic drugs

- Receiving other counseling or therapy

Study Design


Intervention

Behavioral:
Cognitive Behavioral Therapy-Based Group Counseling
Relaxation techniques Providing personal development books Sharing the factors affecting the situation defined as depression (brainstorming) Explaining the link between depressive symptoms, thoughts, feelings, and behaviors Explaining automatic thoughts Application of relaxation techniques; deep-breathing exercises Identifying alternative thoughts Explaining the correlation between alternative thoughts and mood Introduction of the Automatic-Thought Registration Form and distribution to students Describing the effects of depression on social interaction Explaining activities that could be done individually and with the group Distribution of the activity list to students Description of ways of coping with stress Determination of individual stressors and their effects Planning for the future: preventing depression Discussion of assumptions/expectations about life Homeworks related to session contents

Locations

Country Name City State
Turkey Sati Demir Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Beck Depression Inventory (BDI) It measures the risk level of depression. It has 21 items. Each item is scored 0-3 points and the total score ranges from 0-63 (0-9=no; 10-16= mild; 17-20= moderate; 21-26=high; 27 or more points severe depressive symptoms) Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Primary Beck Anxiety Inventory (BAI) This self-assessment scale determines anxiety level. It consists of 21 items. Each item is scored 0-3 points and the total score ranges from 0-63. As the total score increases, the anxiety level increases. Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Primary Automatic Thoughts Questionnaire (ATQ) It measures the thought patterns and negative self-assessments commonly seen in depression. It consists of 30 items. Each item is scored 1-5 points and the total score ranges from 30-150 points. A high score indicates that the frequency of automatic thoughts related to depression is high. Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Primary Ways of Coping Questionnaire (WCQ) It measures the thought patterns and negative self-assessments commonly seen in depression. It consists of 30 items. Each item is scored 1-5 points and the total score ranges from 30-150 points. A high score indicates that the frequency of automatic thoughts related to depression is high. Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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