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Cognitive Behavioral Therapy-Based Group Counseling (CBTBGC)

Primary Purpose

Depression Moderate, Depression Mild

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy-Based Group Counseling
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression Moderate focused on measuring depression, cognitive behavioral therapy, group counseling, nursing students

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Satı Demir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy-Based Group Counseling

Control group

Arm Description

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.

No counseling was given to the control group during the study.

Outcomes

Primary Outcome Measures

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)
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2019
Last Updated
December 9, 2019
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04192721
Brief Title
Cognitive Behavioral Therapy-Based Group Counseling
Acronym
CBTBGC
Official Title
Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
February 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Moderate, Depression Mild
Keywords
depression, cognitive behavioral therapy, group counseling, nursing students

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study used a randomized control clinical trial design. In the BDI pre-test, 80 of the students with mild or moderate depressive symptoms met the other inclusion criteria of the study and volunteered to participate in the study. Out of 80 participants, 40 were randomly assigned to the intervention group and 40 to the control group using computer-generated random number sequences. The study was completed with a total of 63 participants (n=31 for the intervention group; n=32 for the control group). While CBT-based group counseling was given to the intervention group, no counseling was given to the control group during the study. The participants were evaluated at three time points: at screening (pre-test), six weeks after screening (post-intervention/post-test), and two months after the post-test. The measurements were taken simultaneously in the intervention and control groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy-Based Group Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No counseling was given to the control group during the study.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy-Based Group Counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
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)
Time Frame
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Title
Automatic Thoughts Questionnaire (ATQ)
Description
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.
Time Frame
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Title
Ways of Coping Questionnaire (WCQ)
Description
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.
Time Frame
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satı Demir, PhD
Organizational Affiliation
Gazi University Health Sciences Faculty, Ankara, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Satı Demir
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Other researchers will be able to read detailed information such as the research method and results when the research is published. The "Research Protocol" will be available on the this PRS page.

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Cognitive Behavioral Therapy-Based Group Counseling

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