NCT06037005

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 26, 2024

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 7, 2023

Last Update Submit

February 23, 2024

Conditions

Keywords

NurseTherapyPost-Traumatic Stress

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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).

  • Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Third assessment will take place average 12 weeks after the second assessment.

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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).

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a first year nursing student

You may not qualify if:

  • Being a foreign student
  • Having a psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fatma Yener Özcan

Meram, Konya, Turkey (Türkiye)

Location

Burcu CEYLAN

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Single-blinded study with parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 7, 2023

First Posted

September 14, 2023

Study Start

May 10, 2022

Primary Completion

September 30, 2022

Study Completion

November 30, 2023

Last Updated

February 26, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations