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What is the effect of a stabilising group treatment in complex PTSD patients? A Multicenter Randomised Clinical Trial for women with Child Abuse related Post Traumatic Stress Disorder with Associated Features.


- candidate number2021
- NTR NumberNTR631
- ISRCTNISRCTN00874587
- Date ISRCTN created28-apr-2006
- date ISRCTN requested25-apr-2006
- Date Registered NTR17-mrt-2006
- Secondary IDsN/A 
- Public TitleWhat is the effect of a stabilising group treatment in complex PTSD patients? A Multicenter Randomised Clinical Trial for women with Child Abuse related Post Traumatic Stress Disorder with Associated Features.
- Scientific TitleThe effectiveness of a stabilising group treatment in females with complex PTSD patients: A Multicenter Randomised Controlled Trial.
- ACRONYMN/A
- hypothesisThe effectiveness of a 20-week stabilising group therapy in patients with complex PTSD is superior to treatment as usual.
- Healt Condition(s) or Problem(s) studiedPost-Traumatic Stress Disorder (PTSD)
- Inclusion criteriaFemales diagnosed with Complex PTSD according to SCID-DESNOS with or without comorbid axis I or axis II disorders (see also exclusion criteria).
- Exclusion criteriaComorbid psychotic disorders, substance dependence; antisocial personality disorder or dissociative identity disorder, all diagnosed with SCID-I, SCID-D or SCID-II.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 20-mrt-2006
- planned closingdate20-mrt-2009
- Target number of participants72
- Interventions20-week group stabilising treatment for complex PTSD plus TAU vs TAU alone.
- Primary outcome1. CAPS and Davidson Trauma Scale (severity of PTSD symptoms); 2. SCID-DESNOS (overall severity of complex PTSD symptoms); 3. Borderline Personality Disorder Severity Index (BPDSI) (severity of affect-dysregulation and selfdestructiveness); 4. Dissociative Experiences Scale (DES).
- Secondary outcome1. SE (Self Esteem measure); 2. SDQ (somatic dissociation); 3. WHO- QoL (Quality of Life); 4. SCL-90 (comorbid psychopathology); 5. BDI (depression); 6. STAI (anxiety).
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. A.J.L.M. Balkom, van
- CONTACT for SCIENTIFIC QUERIESProf. Dr. A.J.L.M. Balkom, van
- Sponsor/Initiator VU University Medical Center, Department of Psychiatry and GGZ Buitenamstel
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsDorrepaal, E., Thomaes, K., Draijer, P.J. (2006). Stabilisation therapy as an answer to complex post-traumatic stress disorder. Complex post-traumatic stress disorder in woman abused in childhood: progress in diagnostics, treatment and research. Tijdschrift voor Psychiatrie, 3: 217-222.
- Brief summaryThe aim of this randomised controlled trial is to improve and implement outpatient treatment for severely traumatized women with ‘PTSD with associated features’ in terms of DSM-IV-TR. Especially after interpersonal traumatization in childhood PTSD - re-experiencing, numbing and hyper arousal - is complicated by personality changes such as affect dysregulation, memory disturbances, dissociation, disturbances of self-image, somatization and relational problems. This chronic syndrome is called 'PTSD with enduring personality change' in ICD-10, ‘complex PTSD’ or 'disorders of extreme stress NOS'. It is associated with severe psychiatric symptoms, high morbidity, social maladjustment and tends to run a chronic course in spite of considerable use of medical and psychiatric services. Regular PTSD exposure treatment does not lead to improvement and recent Dutch research showes a lack of adequate treatment. There is some evidence that stabilising group therapy is the most effective treatment with psycho-education and a cognitive behavioural training as techniques. In this multicenter trial the first aim is to study the effectiveness of a 20 weekly stabilising group therapy based on Zlotnick as supplement to treatment as usual compared to TAU alone. Criteria (core symptoms) will be symptoms of C-PTSD (see above). The second aim is to identify prognostic variables: hypothesis is that the severity of dissociative symptoms (interfering with attention) and the severity of borderline symptoms (interfering with compliance) will affect success. Four centres of outpatient mental health care will participate. Assessments and treatment protocol have been successfully tested in a pilot study.
- Main changes (audit trail)
- RECORD17-mrt-2006 - 16-jun-2006


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