CBTBGC: Cognitive Behavioral Therapy-Based Group Counseling

Sponsor

Gazi University (Other)

Overall Status

Completed

CT.gov ID

NCT04192721

Collaborator

(none)

Enrollment

Location

Arms

3.7

Actual Duration (Months)

16.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Moderate Depression Mild	Behavioral: Cognitive Behavioral Therapy-Based Group Counseling	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

Controlled, Randomized, Cognitive Behavioral Therapy-Based Group Counseling for Nursing Students With Depressive Symptoms

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Dec 29, 2017

Actual Study Completion Date :

Feb 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	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
No Intervention: Control group No counseling was given to the control group during the study.

Arm

Intervention/Treatment

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.

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

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

Beck Depression Inventory (BDI) [Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)]
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) [Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)]
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) [Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)]
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) [Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Satı Demir	Ankara		Turkey	06500

Sponsors and Collaborators

Gazi University

Investigators

Principal Investigator: Satı Demir, PhD, Gazi University Health Sciences Faculty, Ankara, Turkey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Satı Demir, Principal Investigator, Gazi University

ClinicalTrials.gov Identifier:

NCT04192721

Other Study ID Numbers:

SDemir

First Posted:

Dec 10, 2019

Last Update Posted:

Dec 10, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Satı Demir, Principal Investigator, Gazi University

depression

cognitive behavioral therapy

group counseling

nursing students

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Dec 10, 2019