Clinical trial NCT06384508: Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR
Official title: The Effectiveness of a Virtual Reality Intervention on Trauma-related Shame in Sexually Abused Adolescents: A Single-case Experimental Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shame
Keywords: shame
sexual abuse
virtual reality
self-compassion
Lead sponsor: Universiteit Leiden
Sponsor class: OTHER
Collaborators: name: University of Amsterdam
First posted: 2024-04-25
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Case Experimental Design (ABC) with two different baseline lengths
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Trauma-related shame
timeFrame: Daily throughout the 6 weeks, resulting in 42 assessments
measure: Self-compassion
timeFrame: Daily throughout the 6 weeks, resulting in 42 assessments
Secondary outcomes:
measure: PTSD symptoms
timeFrame: Daily on weekdays throughout the 6 weeks, resulting in 30 assessments
measure: Treatment motivation
timeFrame: Once weekly before the VR session, resulting in 3 assessments
Other outcomes:
Locations:
city: Den Haag
country: Netherlands
facility: GGZ Delfland
state: Haaglanden
city: Leiden
country: Netherlands
facility: iMindU Practice for Child, Adolescent and Adult Psychiatry
state: South Holland
city: Amsterdam
country: Netherlands
facility: LEVVEL
city: Haarlem
country: Netherlands
facility: Kenter Jeugdhulp
city: Oegstgeest
country: Netherlands
facility: LUMC Curium
Study officials:
References:
citation: 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.
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.
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.
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.