- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06037005
The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students
The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students in the COVID 19 Process: Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tekirdağ, Turkey
- Burcu CEYLAN
-
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Konya
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Meram, Konya, Turkey
- Fatma Yener Özcan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being a first year nursing student
Exclusion Criteria:
- Being a foreign student
- Having a psychiatric diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: 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).
|
First assessment will be made at the baseline (pre-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: 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).
|
The second assessment will take place 5 weeks after the first assessment (after the program is completed).
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time Frame: 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).
|
Third assessment will take place average 12 weeks after the second assessment.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDTNurse
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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