Cognitive Behavioral Therapy-Based Group Counseling

NCT04192721 | Completed

• 1 other identifier: SDemir
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression Moderate; Depression Mild

Keywords

depression; cognitive behavioral therapy; group counseling; nursing students

Outcome Measures

Primary Outcomes (4)

• 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)

  Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)

• 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.

  Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)

• 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.

  Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)

• 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.

  Change from baseline to 6 weeks (also assessed at 14 weeks post-baseline)

Study Arms (2)

Cognitive Behavioral Therapy-Based Group Counseling

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Cognitive Behavioral Therapy-Based Group Counseling 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

Cognitive Behavioral Therapy-Based Group Counseling

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Having substance abuse
• Having another psychiatric diagnosis
• Using psychotropic drugs
• Receiving other counseling or therapy

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Satı Demir

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Satı Demir, PhD

  Gazi University Health Sciences Faculty, Ankara, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 10, 2019
• Study Start: November 1, 2017
• Primary Completion: December 29, 2017
• Study Completion: February 23, 2018
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)