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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05368779
Other study ID # 19-10T/43
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2019
Est. completion date June 30, 2021

Study information

Verified date May 2022
Source Bozok University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intimate partner abuse is very common among university students. Post-traumatic stress disorder is one of the most serious mental diseases caused by intimate partner abuse.The purpose of this study was to assess the impact of an internet-based psychosocial intervention based on Social Learning Theory and Cognitive Behavioral Therapy approaches on post-traumatic stress and growth in student nurses who had experienced intimate partner abuse.


Description:

Background: Intimate partner abuse is very common among university students. Post-traumatic stress disorder is one of the most serious mental diseases caused by intimate partner abuse. An intervention with evidence-based applications to post-traumatic stress caused by intimate partner abuse and posttraumatic growth, using web-based applications that young people are familiar with, is considered important in order to protect the physical-mental health of university students, to increase their academic success, and to ensure that they establish healthy intimate partner relationships in the future. Objective: The purpose of this study was to assess the impact of an internet-based psychosocial intervention based on Social Learning Theory and Cognitive Behavioral Therapy approaches on post-traumatic stress and growth in student nurses who had experienced intimate partner abuse. Methods: The randomized controlled study that did not use blinding employed a 2x5 split-plot design. The universe of the study consisted of 371 student nurses. Students who met the eligibility criteria were randomly assigned to one of the two groups: experimental (n=17) and control (n=18). The internet-based psychosocial intervention, which was based on Social Learning Theory and Cognitive Behavioral Therapy techniques, was delivered individually and electronically to the students in the experimental group in eight sessions, each lasting up to 120 minutes, using videoconferencing. The Impact of Events Scale-Revised (IES-R) and the Posttraumatic Growth Inventory (PGTI) were used to measure the outcomes at the pre-test, post-test, 1-month follow-up, 3-month follow-up, and 6-month follow-up. Discussion: The internet-based psychosocial intervention was found to be effective in reducing post-traumatic stress and experiencing post-traumatic growth in student nurses who had been exposed to partner violence with these positive effects lasting for six months. This study is one of the first web-based randomized controlled studies to address post-traumatic stress and growth together in university students who were exposed to intimate partner violence. It is hoped that the results of the study will guide the research to be carried out in this context by internet intervention in the future. * This research was carried out as part of the Ege University Institute of Health Sciences Psychiatric Nursing Doctoral Thesis. Funding: No funding


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 30, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Must be at least 18 years of age - Must have access to a computer and internet - Must able to read and understand the Turkish language - Must experience intimate partner abuse - Must break up with the abuse perpetrator intimate partner - Must be on a current stable dose of psychiatric medication (for at least the last 3 months) or do not use psychiatric medication - Must display symptoms of post-traumatic stress (must get a score of 24 or more in the Impact of Events Scale-Revised) Exclusion Criteria: - Have be currently married - Have a high risk of suicide - Have a psychotic symptom - Have a dissociative symptom - Have a risky alcohol and substance use - Have a receive a non-drug psychiatric treatment

Study Design


Intervention

Behavioral:
The internet-based psychosocial intervention
Participants were provided psychoeducation on intimate partner abuse, psychological trauma, Social Learning Theory, and Cognitive Behavioral Therapy methods. Intimate partner abuse and psychological trauma were discussed in the context of sociocultural factors. Cognitive Behavioral Therapy approaches were used to attempt to normalize intimate partner abuse, psychological trauma and their effects on participants. Participants were exposed to trauma gradually with record of sessions watching and imaginary exposure methods for reducing avoidance behaviours. Schemas, intermediate beliefs, and automatic thoughts of participants were studied using Cognitive Behavioral Therapy approaches and cognitive restructuring was fulfilled. The universality of mental pain, the meaning of life, the integrate trauma into life histories of participants, expectations for the future romantic relationships, and post traumatic growth were all discussed in accordance with the goals and values of participants.

Locations

Country Name City State
Turkey Bozok University Yozgat

Sponsors (2)

Lead Sponsor Collaborator
Bozok University Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pre-intervention post-traumatic stress levels of participants in the experimental and control groups The post-traumatic stress levels of the participants in the experimental and control groups were measured by the Impact of Event Scale-Revised. Impact of Event Scale-Revised has a scoring range of 0 to 88. The cut-off point for post-traumatic stress disorder in the Turkish validity and reliability study of the scale was determined as 24 points. The level of post-traumatic stress increases as the score obtained from Impact of Event Scale-Revised increases. Pre-test (pre-internet-based psychosocial intervention)
Primary Post-intervention post-traumatic stress levels of participants in the experimental and control groups The post-traumatic stress levels of the participants in the experimental and control groups were measured by the Impact of Event Scale-Revised. Impact of Event Scale-Revised has a scoring range of 0 to 88. The cut-off point for post-traumatic stress disorder in the Turkish validity and reliability study of the scale was determined as 24 points. The level of post-traumatic stress increases as the score obtained from Impact of Event Scale-Revised increases. Post-test (immediately after the end of the internet-based psychosocial intervention)
Primary 1-month follow-up post-traumatic stress levels of participants in the experimental and control groups The post-traumatic stress levels of the participants in the experimental and control groups were measured by the Impact of Event Scale-Revised. Impact of Event Scale-Revised has a scoring range of 0 to 88. The cut-off point for post-traumatic stress disorder in the Turkish validity and reliability study of the scale was determined as 24 points. The level of post-traumatic stress increases as the score obtained from Impact of Event Scale-Revised increases. 1-month follow-up (one month after internet-based psychosocial intervention)
Primary 3-month follow-up post-traumatic stress levels of participants in the experimental and control groups The post-traumatic stress levels of the participants in the experimental and control groups were measured by the Impact of Event Scale-Revised. Impact of Event Scale-Revised has a scoring range of 0 to 88. The cut-off point for post-traumatic stress disorder in the Turkish validity and reliability study of the scale was determined as 24 points. The level of post-traumatic stress increases as the score obtained from Impact of Event Scale-Revised increases. 3-month follow-up (three month after internet-based psychosocial intervention)
Primary 6-month follow-up post-traumatic stress levels of participants in the experimental and control groups The post-traumatic stress levels of the participants in the experimental and control groups were measured by the Impact of Event Scale-Revised. Impact of Event Scale-Revised has a scoring range of 0 to 88. The cut-off point for post-traumatic stress disorder in the Turkish validity and reliability study of the scale was determined as 24 points. The level of post-traumatic stress increases as the score obtained from Impact of Event Scale-Revised increases. 6-month follow-up (six month after internet-based psychosocial intervention)
Primary Pre-intervention post-traumatic growth levels of participants in the experimental and control groups The post-traumatic growth levels of the participants in the experimental and control groups were measured by the Posttraumatic Growth Inventory.Posttraumatic Growth Inventory has a scoring range of 0 to 105. The cut-off point for post-traumatic growth of the scale was accepted as 63 points. The level of post-traumatic growth increases as the score obtained from Posttraumatic Growth Inventory increases. Pre-test (pre-internet-based psychosocial intervention)
Primary Post-intervention post-traumatic growth levels of participants in the experimental and control groups The post-traumatic growth levels of the participants in the experimental and control groups were measured by the Posttraumatic Growth Inventory.Posttraumatic Growth Inventory has a scoring range of 0 to 105. The cut-off point for post-traumatic growth of the scale was accepted as 63 points. The level of post-traumatic growth increases as the score obtained from Posttraumatic Growth Inventory increases. Post-test (immediately after the end of the internet-based psychosocial intervention)
Primary 1-month follow-up post-traumatic growth levels of participants in the experimental and control groups The post-traumatic growth levels of the participants in the experimental and control groups were measured by the Posttraumatic Growth Inventory.Posttraumatic Growth Inventory has a scoring range of 0 to 105. The cut-off point for post-traumatic growth of the scale was accepted as 63 points. The level of post-traumatic growth increases as the score obtained from Posttraumatic Growth Inventory increases. 1-month follow-up (one month after internet-based psychosocial intervention)
Primary 3-month follow-up post-traumatic growth levels of participants in the experimental and control groups The post-traumatic growth levels of the participants in the experimental and control groups were measured by the Posttraumatic Growth Inventory.Posttraumatic Growth Inventory has a scoring range of 0 to 105. The cut-off point for post-traumatic growth of the scale was accepted as 63 points. The level of post-traumatic growth increases as the score obtained from Posttraumatic Growth Inventory increases. 3-month follow-up (three month after internet-based psychosocial intervention)
Primary 6-month follow-up post-traumatic growth levels of participants in the experimental and control groups The post-traumatic growth levels of the participants in the experimental and control groups were measured by the Posttraumatic Growth Inventory.Posttraumatic Growth Inventory has a scoring range of 0 to 105. The cut-off point for post-traumatic growth of the scale was accepted as 63 points. The level of post-traumatic growth increases as the score obtained from Posttraumatic Growth Inventory increases. 6-month follow-up (six month after internet-based psychosocial intervention)
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