|- candidate number||28583|
|- NTR Number||NTR7029|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-feb-2018|
|- Secondary IDs||2018-CP-8752 |
|- Public Title||Virtual reality imagery rescripting in PTSD patients: A proof of concept pilot study|
|- Scientific Title||Virtual reality imagery rescripting in PTSD patients: A proof of concept pilot study|
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD), Virtual Reality|
|- Inclusion criteria||- Primary diagnosis of PTSD, as established with a structured diagnostic interview (MINI, SCID, or CAPS).|
- Index trauma is childhood (<16) sexual abuse.
- Conventional ImRs should be an appropriate treatment if patients were treated outside of the study.
- 16 years or older.
- Sufficient fluency in Dutch to complete research procedures (informed consent and study measures).
- Willingness to provide written informed consent.
|- Exclusion criteria||- Other psychopathology that requires immediate other treatment or that would hinder study participation.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2018|
|- planned closingdate||1-sep-2018|
|- Target number of participants||6|
|- Interventions||(1) Imagery Rescripting (active control treatment)|
(2) Virtual Reality Imagery Rescripting (experimental treatment)
|- Primary outcome||PTSD Checklist for DSM-5 (PCL-5)|
|- Secondary outcome||Hospital Anxiety and Depression Scale (HADS)|
Post-Traumatic Cognitions Inventory (PTCI)
Non-fear emotion (e.g., guilt, anger, shame) items (added to PCL-5)
|- Timepoints||Primary outcome (PCL-5) is administered weekly troughout the study.|
Secondary outcomes are administered at every study phase change.
Presence of PTSD is assessed at the start (when evaluating the in-/exclusion criteria) and end of the study.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||PhD A.A.P. Emmerik, van|
|- CONTACT for SCIENTIFIC QUERIES||PhD A.A.P. Emmerik, van|
|- Sponsor/Initiator ||University of Amsterdam (UvA), Department of Clinical Psychology , PsyQ Purmerend, Technische Universiteit Delft|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||16-feb-2018 - 8-mrt-2018|