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

Trauma and Stressor Related Disorders Clinical Trial

Official title:

The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students in the COVID 19 Process: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037005
• Other study ID #: BDTNurse
• Status: Completed
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Necmettin Erbakan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being a first year nursing student

Exclusion Criteria:

• Being a foreign student

• Having a psychiatric diagnosis

Related Conditions & MeSH terms

• Trauma and Stressor Related Disorders

Intervention

Other:
• Cognitive Behavioral Therapy Group
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).

Locations

Country	Name	City	State
Turkey	Fatma Yener Özcan	Meram	Konya
Turkey	Burcu CEYLAN	Tekirdag

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	First assessment will be made at the baseline (pre-intervention)
Secondary	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).	The second assessment will take place 5 weeks after the first assessment (after the program is completed).
Secondary	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).	Third assessment will take place average 12 weeks after the second assessment.