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The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students

Primary Purpose

Trauma and Stressor Related Disorders

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy Group
Sponsored by
Necmettin Erbakan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Trauma and Stressor Related Disorders focused on measuring Nurse, Therapy, Post-Traumatic Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Being a first year nursing student Exclusion Criteria: Being a foreign student Having a psychiatric diagnosis

Sites / Locations

  • Fatma Yener Özcan
  • Burcu CEYLAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy

Control

Arm Description

Expert support was received from the Cognitive Behavioral Psychotherapy Practitioner and Trainer of the Turkish Psychiatric Association in the creation of the sessions. The researcher applying the therapy has a CBT practitioner certificate. Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).

While group therapy was applied to the experimental group, no intervention was made to the control group.

Outcomes

Primary Outcome Measures

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).

Secondary Outcome Measures

Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).

Full Information

First Posted
September 7, 2023
Last Updated
September 7, 2023
Sponsor
Necmettin Erbakan University
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1. Study Identification

Unique Protocol Identification Number
NCT06037005
Brief Title
The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students
Official Title
The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students in the COVID 19 Process: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Objectives: This research was planned to examine the effect of cognitive behavioral therapy on the post-traumatic stress symptoms of nursing students during the COVID-19 pandemic. Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants: 60 first-year students studying at the Faculty of Nursing were randomly assigned to the intervention (n=30) and control (n=30) groups. Method: Data were collected using the Information Form prepared by the researcher and the Post Traumatic Stress Disorder Checklist for DSM-5. The intervention group was collected online three times, before the cognitive behavioral group therapy, at the end of the therapy and three months later. Group intervention program based on cognitive behavioral approach of ten sessions; face-to-face, the intervention group was divided into two separate groups and each group was completed in approximately one and a half months (May-June 2022), two days a week. Follow-up measurement was completed in September 2022. While group therapy was applied to the intervention group, no intervention was made to the control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma and Stressor Related Disorders
Keywords
Nurse, Therapy, Post-Traumatic Stress

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blinded study with parallel groups.
Masking
Outcomes Assessor
Masking Description
In the study, data collection, statistics and reporting were blinded. The collection of research data and data entry (pre-tests and post-tests and transferring the data to the computer) were carried out by an instructor other than the researcher, who was unaware of the intervention and control groups. Data entries were entered with "A" and "B" codes without specifying the intervention or control group. The analysis of the data and the writing of the research report were coded as "A" and "B" groups. After the statistical analysis was made and the research report was written, the coding for the intervention and control groups was explained to the researcher by the coder.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Expert support was received from the Cognitive Behavioral Psychotherapy Practitioner and Trainer of the Turkish Psychiatric Association in the creation of the sessions. The researcher applying the therapy has a CBT practitioner certificate. Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).
Arm Title
Control
Arm Type
No Intervention
Arm Description
While group therapy was applied to the experimental group, no intervention was made to the control group.
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioral Therapy Group
Intervention Description
Group intervention program based on cognitive behavioral approach of ten sessions; It was completed in approximately one and a half months (May-June 2022) in the Faculty of Nursing, by dividing the experimental group into two separate groups, two days a week for each group. Each session was held for approximately one hour. The last measurement was made three months after the last therapy session (September 2022).
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Description
Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
Time Frame
First assessment will be made at the baseline (pre-intervention)
Secondary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Description
Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
Time Frame
The second assessment will take place 5 weeks after the first assessment (after the program is completed).
Title
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Description
Using the Post-Traumatic Stress Disorder Checklist for the DSM-5, symptoms of post-traumatic stress are assessed. Scores ranging from 0 to 80 points are obtained in the scale. In the interpretation of the results of the scale, it gives information about the level of symptoms by calculating the total symptom score together with the sum of the scores of the symptoms in each item, and it is recommended to use 28 as the cut-off point, although it varies according to the purpose of use (Blevins et al., 2015).
Time Frame
Third assessment will take place average 12 weeks after the second assessment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being a first year nursing student Exclusion Criteria: Being a foreign student Having a psychiatric diagnosis
Facility Information:
Facility Name
Fatma Yener Özcan
City
Meram
State/Province
Konya
Country
Turkey
Facility Name
Burcu CEYLAN
City
Tekirdağ
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students

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