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

NCT06384508 | Completed DMC

• 1 other identifier: NL83340.058.23
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Shame

Keywords

shame; sexual abuse; virtual reality; self-compassion

Outcome Measures

Primary Outcomes (2)

• 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.

  Daily throughout the 6 weeks, resulting in 42 assessments

• 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.

  Daily throughout the 6 weeks, resulting in 42 assessments

Secondary Outcomes (1)

• PTSD symptoms

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

Study Arms (2)

SHINE-VR Baseline 1 week

ACTIVE COMPARATOR

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

SHINE-VR Baseline 2 weeks

ACTIVE COMPARATOR

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

SHINE-VR BEHAVIORAL

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.

SHINE-VR Baseline 1 week; SHINE-VR Baseline 2 weeks

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known mental disability
• Epilepsy

Sponsors & Collaborators

• Universiteit Leiden: lead
• University of Amsterdam: collaborator

Study Sites (5)

GGZ Delfland

The Hague, Haaglanden, Netherlands

Location

iMindU Practice for Child, Adolescent and Adult Psychiatry

Leiden, South Holland, 2311 EX, Netherlands

Location

LEVVEL

Amsterdam, Netherlands

Location

Kenter Jeugdhulp

Haarlem, Netherlands

Location

LUMC Curium

Oegstgeest, 2342AK, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 27318595 RESULT

• 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.

  PMID: 32125190 RESULT

• 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.

  PMID: 35928521 RESULT

• 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.

  PMID: 18245208 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants are unaware of different baseline lengths
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single Case Experimental Design (ABC) with two different baseline lengths

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: April 25, 2024
• Study Start: February 3, 2025
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We will store the data according to the University regulations on data management of projects assessed by the Medical Ethical committee, allowing the data to be FAIR for at least 15 years after publication.
• Access Criteria: A CC-BY license will be used. Since sensitive data will be collected, it will only be shared with researchers upon request. Requests for information will be reviewed by the first and last author.

Locations

NL (5)