Rumination
Conditions
Keywords
virtual reality, brain stimulation, tDCS, phenomenology
Brief summary
This study proposes: to evaluate 1) whether the combination of virtual reality (VR) and active tDCS provides better rumination attenuation than the combination of VR and tDCS placebo 2) the acceptability and experiential experience of combining these two well known medical devices.
Detailed description
Inclusion visit: * Confirmation of eligibility criteria * Written informed consent Visit 1 and 2 (or end of study visit) : Before first ruminations induction : * Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Ruminative Response Scale - Short Form (RRS-SF), Beck depression Inventory (BDI) * EEG recording Then Procedure for inducing ruminations using a pre-recorded voice listened to in an audio headset alternating statements promoting a positive, neutral and negative introspection and self-judgment attitude (the latter are heard at the end to initiate the rumination process) over 8 minutes Then * Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), * EEG recording * Pulse and blood pressure measurements Then immersion in a relaxing virtual environment for 20 minutes with active or sham placebo. • Cutaneous conductance measurement and eye-tracking during immersion At the end of immersion : * Completion of Brief State Rumination Inventory (BSRI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), IGroup presence questionnaire (IPQ) * Pulse and blood pressure measurements Then again procedure for inducing ruminations . At the end of ruminations induction : * Completion of Brief State Rumination Inventory (BSRI), State-Trait Anxiety (STAI), Inventory, Visual Analogic Scale (VAS), Beck depression Inventory (BDI), tolerance questionnaires * Debriefing
Interventions
Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
DEVICEVR +sham brain stimulation
Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Without any particular ethnic and psychosocial criteria * Subject to ruminations (personality trait) documented by a RRS-SF score \>30 * Subjects with score to BDI scal \<14 assessed during first visit * Subjects without psychiatric or addictive disorders. * Subjects who do not meet all the diagnostic criteria for an anxiety disorder or characterized depressive episode.
Exclusion criteria
* contraindication to tDCS (neurosurgical history, intracranial device, skin problems) * current virtual reality intolerance * history of psychiatric or addictive disorders * Use of psychotropic drugs * Use of non psychotropic treatments significantly influencing mood or level of anxiety * pregnant or breast-feeding women * Neurological pathology, locomotor disability, or sensory (vestibular, visual, auditory ...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxious ruminations after anodal tDCS and virtual reality | within 1 week | Change in anxious ruminations after anodal tDCS and virtual reality will be evaluated to compare the effects of tDCS associated with virtual reality versus virtual reality alone (+ tDCS placebo) to reduce ruminations. Evaluate with Brief State Ruminative Inventory (BSRI). It is a scale with 8 items. Each item is VAS with a score ranging between 0 and 100. The total score is sum of each item score (Total /800) |
Countries
France
Outcome results
None listed