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Violence, SexualNCT05368779

Online Psychosocial Intervention for Nursing Students Who Experienced Intimate Partner Abuse in Turkey

A study testing The internet-based psychosocial intervention in people with Violence, Sexual and Violence, Physical, run by Bozok University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
The internet-based psychosocial intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Oct 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bozok University

    Yozgat

Other trials in Turkey (Türkiye)

About this study

Official title: Online Psychosocial Intervention for Nursing Students Who Experienced Intimate Partner Abuse in Turkey: A Randomized Controlled Trial

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.

Read the detailed 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

Being tested
The internet-based psychosocial intervention
Medical subject headings
Coitus, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The internet-based psychosocial interventionBehavioural

    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.

Study groups in NCT05368779
Study groupRoleWhat they receive
Internet-based Psychosocial Intervention GroupExperimentalThe 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.
Receives: Behavioral: The internet-based psychosocial intervention
Control GroupNo interventionNo intervention was applied to the participants in the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-test (pre-internet-based psychosocial intervention)

  2. 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.

    Measured: Post-test (immediately after the end of the internet-based psychosocial intervention)

  3. 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.

    Measured: 1-month follow-up (one month after internet-based psychosocial intervention)

  4. 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.

    Measured: 3-month follow-up (three month after internet-based psychosocial intervention)

  5. 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.

    Measured: 6-month follow-up (six month after internet-based psychosocial intervention)

  6. 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.

    Measured: Pre-test (pre-internet-based psychosocial intervention)

  7. 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.

    Measured: Post-test (immediately after the end of the internet-based psychosocial intervention)

  8. 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.

    Measured: 1-month follow-up (one month after internet-based psychosocial intervention)

  9. 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.

    Measured: 3-month follow-up (three month after internet-based psychosocial intervention)

  10. 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.

    Measured: 6-month follow-up (six month after internet-based psychosocial intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start2 Oct 2019
  3. Primary completion31 May 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05368779
Sponsor's protocol ID
19-10T/43
Status last verified
May 2022
First submitted
27 Apr 2022
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The internet-based psychosocial intervention in people with Violence, Sexual and Violence, Physical, run by Bozok University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-intervention post-traumatic stress levels of participants in the experimental and control groups (time frame: Pre-test (pre-internet-based psychosocial intervention)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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