- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384508
Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR (SHINE-VR)
The Effectiveness of a Virtual Reality Intervention on Trauma-related Shame in Sexually Abused Adolescents: A Single-case Experimental Study
Suffering from PTSD in childhood can have detrimental formative consequences. Researchers have been eager to develop effective interventions and to enhance treatment motivation since the introduction of the diagnosis of PTSD in the DSM. With evolving understanding of the disorder, its definition and criteria have changed over the course of time. The most recent change involves the addition of the criterium D of negative affects or emotions in relation to PTSD, the feeling of shame amongst others. Individuals experiencing interpersonal trauma, such as sexual abuse, are at high-risk developing trauma-related shame, which in turn can impact the course and effectiveness of PTSD treatment. Shame-inducing situations are typically being avoided, and the feelings are not disclosed to peers and other people. Hence, acknowledging and sharing feelings of shame as well as practicing self-compassion have been proposed to reduce the impact of that negative self-conscious emotion. These aspects get partially tackled in evidence-based trauma therapies, however, there appears to be a need for a more specific trauma-related shame intervention in addition to existing treatments. Recent research has focused on developing such interventions for adults and has reported positive effects.
To our knowledge, there is no intervention specifically tackling trauma-related shame in adolescents. Virtual Reality (VR) is a promising tool for such an intervention. Findings suggest that including VR in a treatment results in high treatment satisfaction and that it is highly motivating for its users, which is a crucial component for treatment success.
The goal of this study is to test the effectiveness of a short-term VR shame intervention (SHINE-VR) for adolescents suffering from PTSD after having experienced sexual abuse. The primary objectives of this study to assess the effect of SHINE-VR on trauma-related shame, self-compassion, and PTSD symptom reduction, to investigate whether treatment motivation, an increase in self-compassion, and a decrease in trauma-related shame are associated with PTSD symptom reduction.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amsterdam, Netherlands
- LEVVEL
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Haarlem, Netherlands
- Kenter Jeugdhulp
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Oegstgeest, Netherlands, 2342AK
- LUMC Curium
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Haaglanden
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The Hague, Haaglanden, Netherlands
- GGZ Delfland
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South Holland
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Leiden, South Holland, Netherlands, 2311 EX
- iMindU Practice for Child, Adolescent and Adult Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between 12 and 17 years old at inclusion
- Interpersonal trauma (sexual abuse); in case of multiple traumas the main trauma should be sexual abuse
- Indication for PTSD treatment
- Getting trauma treatment as usual
- Adequate command of the Dutch language
Exclusion Criteria:
- Known mental disability
- Epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: SHINE-VR Baseline 1 week
Participants will receive SHINE-VR additionally to regular trauma treatment. The baseline phase starts after trauma processing, e.g. after module 6 of TF-CBT or processing of the traumatic event with EMDR. This group has a one week baseline, 3 weeks intervention, and 2 week follow-up phase. |
The SHINE-VR takes place after trauma processing, e.g. after module 6 of TF-CBT or processing of the traumatic event with EMDR, and is followed by the rest of the regular treatment. SHINE-VR consists of the following 3 VR sessions à 45min:
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Active Comparator: SHINE-VR Baseline 2 weeks
Participants will receive SHINE-VR additionally to regular trauma treatment. The baseline phase starts after trauma processing, e.g. after module 6 of TF-CBT or processing of the traumatic event with EMDR. This group has a two week baseline, 3 weeks intervention, and a 1 week follow-up phase. |
The SHINE-VR takes place after trauma processing, e.g. after module 6 of TF-CBT or processing of the traumatic event with EMDR, and is followed by the rest of the regular treatment. SHINE-VR consists of the following 3 VR sessions à 45min:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trauma-related shame
Time Frame: Daily throughout the 6 weeks, resulting in 42 assessments
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Shame experienced in relation to sexual abuse will be measured with a self-developed questionnaire.
The first 4 items are based on the Dutch translation of the Shame and Guilt After Trauma Scale.
Each item is rated on a 5-point Likert scale.
Higher scores mean worse outcome. 2 items are reversed.
Higher scores mean worse outcome.
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Daily throughout the 6 weeks, resulting in 42 assessments
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Self-compassion
Time Frame: Daily throughout the 6 weeks, resulting in 42 assessments
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Self-compassion will be measured with the Dutch translation of the Self-Compassion Scale-Youth version.
Each of the 6 items is rated on a 1-5 Likert scale, 3 of them are reversed.
The outcome measure is the sum score of all items divided by the number of items.
Higher scores mean better outcome.
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Daily throughout the 6 weeks, resulting in 42 assessments
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PTSD symptoms
Time Frame: Daily on weekdays throughout the 6 weeks, resulting in 30 assessments
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PTSD symptoms will be measured with the Kind en Jeugd Traumascreener.
Items 1-20 measuring the symptoms will be used, each item is rated on a 0-3 Likert scale.
The outcome measure is the sum score of all items.
Higher scores mean worse outcome.
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Daily on weekdays throughout the 6 weeks, resulting in 30 assessments
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Aakvaag HF, Thoresen S, Wentzel-Larsen T, Dyb G, Roysamb E, Olff M. Broken and guilty since it happened: A population study of trauma-related shame and guilt after violence and sexual abuse. J Affect Disord. 2016 Nov 1;204:16-23. doi: 10.1016/j.jad.2016.06.004. Epub 2016 Jun 11.
- Neff KD, Bluth K, Toth-Kiraly I, Davidson O, Knox MC, Williamson Z, Costigan A. Development and Validation of the Self-Compassion Scale for Youth. J Pers Assess. 2021 Jan-Feb;103(1):92-105. doi: 10.1080/00223891.2020.1729774. Epub 2020 Mar 3.
- Sachser C, Berliner L, Risch E, Rosner R, Birkeland MS, Eilers R, Hafstad GS, Pfeiffer E, Plener PL, Jensen TK. The child and Adolescent Trauma Screen 2 (CATS-2) - validation of an instrument to measure DSM-5 and ICD-11 PTSD and complex PTSD in children and adolescents. Eur J Psychotraumatol. 2022 Aug 1;13(2):2105580. doi: 10.1080/20008066.2022.2105580. eCollection 2022.
- Drieschner KH, Boomsma A. Validation of the Treatment Motivation Scales for Forensic outpatient treatment (TMS-F). Assessment. 2008 Jun;15(2):242-55. doi: 10.1177/1073191107311651. Epub 2008 Feb 1.
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NL83340.058.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Identifiable information of the participants will be encrypted for the further processing and analyzing of the corresponding data. Once the project is completed and the paper(s) has been published, the encryption key and the personal data will be deleted. Following paragraph from the template of the Institute of Education and Child Studies will be used:
I consent to my and my child's participation in the study (Title Research) I also give permission to store and use the pseudonymised research data about me and my child that is collected in this research and to share it with other researchers if necessary.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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