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

Shame Clinical Trial

— SHINE-VR  

Official title:

The Effectiveness of a Virtual Reality Intervention on Trauma-related Shame in Sexually Abused Adolescents: A Single-case Experimental Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384508
• Other study ID #: NL83340.058.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Universiteit Leiden
• Contact: Catharina Berwerff, Dr.
• Phone: 71 527 2727
• Email: c.e.bergwerff[@]fsw.leidenuniv.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, and the evaluation of SHINE-VR by assessing the feasibility of the intervention.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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 using TF-CBT

• Adequate command of the Dutch language

Exclusion Criteria:

• Known mental disability

• Epilepsy

Related Conditions & MeSH terms

• Shame

Intervention

Behavioral:
• SHINE-VR
The SHINE-VR takes place after module 6 of TF-CBT and is followed by the rest of the regular treatment. It 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.

Locations

Country	Name	City	State
Netherlands	LEVVEL	Amsterdam
Netherlands	iMindU Practice for Child, Adolescent and Adult Psychiatry	Leiden	South Holland

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Leiden	University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Daily on weekdays throughout the 6 weeks, resulting in 30 assessments
Secondary	Treatment motivation	Treatment motivation will be measured with four self-developed items. Each item is rated on a 1-5 Likert scale. The outcome measure is the sum score divided by the number of items. Higher scores mean better outcome.	Once weekly before the VR session, resulting in 3 assessments