|- candidate number||24456|
|- NTR Number||NTR5931|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jun-2016|
|- Secondary IDs||2335 Innovatiefonds Zorgverzekeraars|
|- Public Title||Intensive PE for treatment-refractory PTSD patients|
|- Scientific Title||The effectiveness and feasibility of brief intensive exposure treatment for treatment-refractory complex PTSD patients: when regular trauma-focused treatment failed. |
|- hypothesis||The present study aims at the improvement of the treatment of adults with treatment-refractory PTSD with an open clinical study examining the effectiveness and feasibility of a brief intensive exposure treatment. |
|- Healt Condition(s) or Problem(s) studied||Post-Traumatic Stress Disorder (PTSD)|
|- Inclusion criteria||(1) Age ≥ 18 years. |
(2) History of multiple interpersonal traumas.
(3) Meeting full DSM-IV diagnostic criteria of PTSD established through the Clinical-Administered PTSD Scale (CAPS).
(4) Lack of treatment response during regular PTSD guideline treatment.
|- Exclusion criteria||(1) Suicide attempt within 8 weeks prior to study entry.|
(2) Inability to speak and write Dutch.
(3) Severe intellectual impairment (IQ≤ 70)
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-jan-2012|
|- planned closingdate||31-dec-2016|
|- Target number of participants||75|
|- Interventions||Brief intensive exposure treatment:|
4 days (spread over two weeks), offered in three blocks of 90 minutes each day and four follow up appointments (90 minutes each).
|- Primary outcome||PTSD symptom severity: |
|- Secondary outcome||- Depressive symptoms: BDI-II|
- Dissociative symptoms: DES
- Autonomy and social optimism: PUL
- Trauma identification: ITSS
- Schizotypy: O-LIFE
|- Timepoints||All measures:|
- before treatment (baseline: A0);
- seven weeks after baseline (post
- 18 weeks after baseline (follow up 1: A2);
- and 30 weeks after baseline (follow up 2:
- time points as defined above;
- as well as in week 3,4,5 and 6 (before follow up appointments).
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr A. Minnen, van|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr A. Minnen, van|
|- Sponsor/Initiator ||Behavioural Science Institute, Radboud University Nijmegen|
(Source(s) of Monetary or Material Support)
|- Brief summary||The present study aims to examine the effectiveness and feasibility of an outpatient brief intensive exposure treatment for treatment-refractory complex PTSD patients. The new treatment program makes use of proven effective therapy techniques in processing the trauma and decreasing PTSD symptoms, whereas the delivery of the treatment is using a new format: 4 days (spread over two weeks).
Country of Recruitment: The Netherlands
|- Main changes (audit trail)|
|- RECORD||13-jun-2016 - 8-aug-2016|