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 are:1) To assess the effect of SHINE…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are trauma-related shame and self-compassion.
Secondary outcome
Secondary parameters are treatment motivation and PTSD symptoms. The
exploratory objective is to evaluate SHINE-VR.
Background 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.
Study objective
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 are:
1) To assess the effect of SHINE-VR on trauma-related shame, self-compassion,
PTSD symptom reduction and PTSD treatment motivation.
2) To investigate whether an increase in self-compassion and treatment
motivation, and a decrease in trauma-related shame are associated with PTSD
symptom reduction.
3) Evaluation SHINE-VR: Assessment of feasibility measures such as usability,
acceptability, tolerability, and satisfaction
Study design
A single case experimental design will be used to evaluate the intervention.
Participants will receive SHINE-VR additionally to the regular trauma
treatment. SHINE-VR is administered by the therapist of the participant.
Intervention
The SHINE-VR takes place after trauma processing and consists of the following
3 VR sessions à 45min:
- Introduction: getting acquainted with VR, playing VR game developed for the
feasibility study (Krupljanin et al., 2023), 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.
Study burden and risks
This study will be testing a short-term VR shame intervention and will as such
be part of regular trauma treatment. Therefore, participants are considered to
have minimal burden in terms of additional travels or other expenses of similar
nature.
There is a minimal risk involved considering the technical nature of the VR
module. Being in VR can lead to so called visually induced motion sickness.
However, studies investigating this phenomenon in children aged 4 years or
older have found no significant changes in subjective physical well-being. As a
measure, all therapists will receive a briefing and a protocol (see document
K6. Protocol for use in case of motion sickness 09-01-23) for symptoms of
motion sickness. These symptoms typically resolve shortly after leaving the
virtual environment. This risk is therefore considered to be minimal.
The participation in this study involves 3 VR sessions, regular trauma
treatment and filling out questionnaires. The therapists themselves will
receive sufficient VR training before delivering the module and regular
meetings with the coordinating investigator. The time burden associated with
filling in the questionnaires depends on the patient, we expect the total
investment, including the VR sessions and filling out daily questionnaires
during the multi-week VR intervention phase, to amount to 422 - 452 minutes (3
extra sessions à 45 minutes and daily questionnaires with an average duration
of 6 minutes). The questionnaires will be programmed online, which has the
advantage of being accessible from the phones or laptops of the participants.
The participants are hypothesized to directly benefit from the intervention;
however, the participants will also receive a gift voucher worth ¤25 and small
gift in the end of the study. The caregivers and the participants are offered a
short summary of the research project after completion of the data collection
at T2. In summary, we believe that the commitment we are asking of the
therapists and the participants is well balanced.
Wassenaarseweg 52 52
Leiden 2333 AK
NL
Wassenaarseweg 52 52
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
- Between 12;0 and 17;11 years old at inclusion
- Indication for PTSD treatment
- Getting trauma treatment as usual
- Interpersonal trauma (sexual abuse); in case of multiple traumas the main
trauma should be sexual abuse
- Adequate command of the Dutch language
Exclusion criteria
- Known mental disability
- Epilepsy
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL83340.058.23 |