Cognitive Behavioral Therapy-Based Group Counseling

NCT ID: NCT04192721

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression Moderate Depression Mild

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

depression cognitive behavioral therapy group counseling nursing students

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy-Based Group Counseling

Intervention Type BEHAVIORAL

* 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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gazi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Satı Demir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Satı Demir, PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University Health Sciences Faculty, Ankara, Turkey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Satı Demir

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SDemir

Identifier Type: -

Identifier Source: org_study_id