Cognitive Behavioral Therapy-Based Group Counseling (CBTBGC)

December 9, 2019 updated by: Satı Demir, Gazi University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06500
        • Satı Demir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory (BDI)
Time Frame: 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)
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Beck Anxiety Inventory (BAI)
Time Frame: 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.
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Automatic Thoughts Questionnaire (ATQ)
Time Frame: 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.
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)
Ways of Coping Questionnaire (WCQ)
Time Frame: 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.
Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Satı Demir, PhD, Gazi University Health Sciences Faculty, Ankara, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDemir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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