Viewing Study NCT06384508



Ignite Creation Date: 2024-05-06 @ 8:26 PM
Last Modification Date: 2024-10-26 @ 3:27 PM
Study NCT ID: NCT06384508
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-15
First Post: 2024-03-01

Brief Title: Decrease Trauma-related Shame With Virtual Reality The Effectiveness of SHINE-VR
Sponsor: Universiteit Leiden
Organization: Universiteit Leiden

Study Overview

Official Title: The Effectiveness of a Virtual Reality Intervention on Trauma-related Shame in Sexually Abused Adolescents A Single-case Experimental Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SHINE-VR
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None