ShameSHINE-VRNCT06384508
Decrease Trauma-related Shame With Virtual Reality: The Effectiveness of SHINE-VR
A study testing SHINE-VR in people with Shame, run by Universiteit Leiden at 5 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Shame
- What is being tested?
- SHINE-VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 5 sitesNetherlands
- Study dates
- 3 Feb 2025to 19 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Known mental disability
- Epilepsy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Netherlands5 sites
LEVVEL
Amsterdam
Kenter Jeugdhulp
Haarlem
iMindU Practice for Child, Adolescent and Adult Psychiatry
Leiden, South Holland, 2311 EX
LUMC Curium
Oegstgeest, 2342AK
GGZ Delfland
The Hague, Haaglanden
About this study
Official title: The Effectiveness of a Virtual Reality Intervention on Trauma-related Shame in Sexually Abused Adolescents: A Single-case Experimental Study
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
- Being tested
- SHINE-VR
- Keywords
- shame, sexual abuse, virtual reality, self-compassion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHINE-VRBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SHINE-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Daily on weekdays throughout the 6 weeks, resulting in 30 assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start3 Feb 2025
- Primary completion19 May 2025
- Study completion19 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ShameStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Case Experimental Design (ABC) with two different baseline lengths
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Leiden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam
- Responsible party
- Principal investigator, Carlijn Bergwerff, Universiteit Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384508
- Sponsor's protocol ID
- NL83340.058.23
- Acronym
- SHINE-VR
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 27318595Neff 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 32125190Sachser 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 35928521Drieschner 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Virtual Reality Intervention on Trauma-related Shame in Sexually Abused Adolescents: A Single-case Experimental Study
- ClinicalTrials.gov ID
- NCT06384508
- Acronym / sponsor ID
- SHINE-VR / NL83340.058.23
- Conditions
- Shame
- Keywords
- shame, sexual abuse, virtual reality, self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Universiteit LeidenUniversity, hospital or other
- Collaborators
- University of Amsterdam
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Case Experimental Design (ABC) with two different baseline lengths
| Arm | Type | Receives |
|---|---|---|
| SHINE-VR Baseline 1 week | Active comparator | Behavioral: SHINE-VRParticipants 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. |
| SHINE-VR Baseline 2 weeks | Active comparator | Behavioral: SHINE-VRParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Known mental disability
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHINE-VRThe 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. | Behavioural | SHINE-VR Baseline 1 week, SHINE-VR Baseline 2 weeks |
Primary outcome
Trauma-related shame
Time frame: Daily throughout the 6 weeks, resulting in 42 assessments
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.
Self-compassion
Time frame: Daily throughout the 6 weeks, resulting in 42 assessments
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.
1 secondary outcome
PTSD symptoms
Time frame: Daily on weekdays throughout the 6 weeks, resulting in 30 assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 27318595Aakvaag 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.
- Results publication: PubMed 32125190Neff 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.
- Results publication: PubMed 35928521Sachser 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.
- Results publication: PubMed 18245208Drieschner 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.
- Individual participant dataSharing planned: 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.
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Shame
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHINE-VR in people with Shame, run by Universiteit Leiden at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trauma-related shame (time frame: Daily throughout the 6 weeks, resulting in 42 assessments). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06384508, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.