NCT05368779

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

April 27, 2022

Last Update Submit

May 6, 2022

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Internet-based Psychosocial Intervention Group

EXPERIMENTAL

The internet-based psychosocial intervention, which was based on Social Learning Theory and Cognitive Behavioral Therapy techniques, was delivered individually and electronically to the participants in the experimental group in eight sessions, each lasting up to 120 minutes, using videoconferencing.

Behavioral: The internet-based psychosocial intervention

Control Group

NO INTERVENTION

No intervention was applied to the participants in the control group.

Interventions

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.

Internet-based Psychosocial Intervention Group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bozok University

Yozgat, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CoitusStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Şeyda Dülgerler, Assoc. Prof.

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 10, 2022

Study Start

October 2, 2019

Primary Completion

May 31, 2021

Study Completion

June 30, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations