CClinicalTrials.gg
CompletedNCT06384508SHINE-VRUpdated Dec 15, 2025

Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR

An interventional study of SHINE-VR in Shame, sponsored by Universiteit Leiden. Completed at 5 sites in Netherlands. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-12-15.

Sponsored by Universiteit Leiden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Shame

Keywords

  • shame
  • sexual abuse
  • virtual reality
  • self-compassion
03

In context

Lead sponsor

Universiteit Leiden is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Known mental disability
  • Epilepsy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • 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.

    Behavioral: SHINE-VR

  • 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.

    Behavioral: SHINE-VR

Interventions

  • BehavioralSHINE-VR

    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: * Introduction: getting acquainted with VR, playing a VR game developed for the feasibility study (Krupljanin et al., in preparation), receiving psychoeducation about seeking help. * Shame: virtual group therapy setting, psychoeducation about shame, virtual peers sharing thoughts of shame and their learnings/positive affirmations. * Self-compassion: practicing self-compassion using an immersive perspective-changing task in VR.

06

What researchers measure

Primary outcomes

  1. Trauma-related shame

    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.

    Time frame: Daily throughout the 6 weeks, resulting in 42 assessments

  2. Self-compassion

    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.

    Time frame: Daily throughout the 6 weeks, resulting in 42 assessments

Secondary outcomes

  1. PTSD symptoms

    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.

    Time frame: Daily on weekdays throughout the 6 weeks, resulting in 30 assessments

07

Study locations

5 sites
  • GGZ Delfland
    The Hague, Haaglanden, Netherlands
  • iMindU Practice for Child, Adolescent and Adult Psychiatry
    Leiden, South Holland 2311 EX, Netherlands
  • LEVVEL
    Amsterdam, Netherlands
  • Kenter Jeugdhulp
    Haarlem, Netherlands
  • LUMC Curium
    Oegstgeest, 2342AK, Netherlands
08

References and documents

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. PubMed 27318595 ↗
  • 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. PubMed 32125190 ↗
  • 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. PubMed 35928521 ↗
  • 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. PubMed 18245208 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06384508
Lead sponsor
Universiteit Leiden
Collaborators
University of Amsterdam
Responsible party
Carlijn Bergwerff (Associate Professor, Universiteit Leiden) — Principal investigator
First posted
Apr 25, 2024
Start date
Feb 3, 2025
Primary completion
May 19, 2025
Completion
May 19, 2025
Last update
Dec 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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