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

• Sponsor: Necmettin Erbakan University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06037005
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 18.7
• Patients Per Site: 30
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Trauma and Stressor Related Disorders	Other: Cognitive Behavioral Therapy Group	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-blinded study with parallel groups.Single-blinded study with parallel groups.
• Masking: Single (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.
• Primary Purpose: Other
• Official Title: The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students in the COVID 19 Process: Randomized Controlled Trial
• Actual Study Start Date: May 10, 2022
• Actual Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral Therapy 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).	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).
No Intervention: Control While group therapy was applied to the experimental group, no intervention was made to the control group.

Outcome Measures

Primary Outcome Measures

1. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [First assessment will be made at the baseline (pre-intervention)]

   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

1. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [The second assessment will take place 5 weeks after the first assessment (after the program is completed).]

   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).

2. Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) [Third assessment will take place average 12 weeks after the second assessment.]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Being a first year nursing student

Exclusion Criteria:

• Being a foreign student

• Having a psychiatric diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fatma Yener Özcan	Meram	Konya	Turkey
2	Burcu CEYLAN	Tekirdağ		Turkey

Sponsors and Collaborators

• Necmettin Erbakan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fatma Yener Ozcan, Research Assistant, Necmettin Erbakan University
• ClinicalTrials.gov Identifier: NCT06037005
• Other Study ID Numbers: BDTNurse
• First Posted: Sep 14, 2023
• Last Update Posted: Sep 14, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fatma Yener Ozcan, Research Assistant, Necmettin Erbakan University: Nurse; Therapy; Post-Traumatic Stress
• Additional relevant MeSH terms: Trauma and Stressor Related Disorders

Study Results

No Results Posted as of Sep 14, 2023