- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192721
Cognitive Behavioral Therapy-Based Group Counseling (CBTBGC)
Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ankara, Turkey, 06500
- Satı Demir
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cognitive Behavioral Therapy-Based Group Counseling
The CBT-based group counseling provided to the intervention group was carried out as a group intervention with structured sessions in which various techniques and methods of CBT, having mainly educational content, were applied, including an experiential interaction process.
The counseling was performed in a total of six 60- to 90-minute sessions, comprising one session per week for four groups consisting of six to 10 members each.
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No Intervention: Control group
No counseling was given to the control group during the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Beck Depression Inventory (BDI)
Time Frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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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)
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Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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Beck Anxiety Inventory (BAI)
Time Frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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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.
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Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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Automatic Thoughts Questionnaire (ATQ)
Time Frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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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.
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Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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Ways of Coping Questionnaire (WCQ)
Time Frame: Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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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.
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Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Satı Demir, PhD, Gazi University Health Sciences Faculty, Ankara, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SDemir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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