- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01033708
A Randomized Control Trial of Narrative Exposure Therapy Versus Treatment as Usual in the Therapy of Borderline Personality Disorder (NET)
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Experimental intervention:
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversity.
Control intervention:
Treatment as usual.
Follow-up per patient:
3 follow-up assessments- 4 weeks, 6 months,12 months and 24 months after end of experimental/ control intervention
Duration of intervention per patient:
Both treatment types will be conducted for 10-14 sessions of 60-90 min in length.
Additionally 5 sleep laboratory investigations (1 pre- and 4 post- intervention (4 weeks, 6 months, 12 months, 24 months after treatment)) will be carried out. Additionally the cortisol level in the hair and epigenetic markers will be recorded. The estimated observation time is 2 years.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kiel, Tyskland, 24105
- Rekruttering
- Zentrum Integrative Psychiatrie
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Kontakt:
- Pabst, psychologist
- Telefonnummer: +49 431 9900 2681
- E-mail: a.pabst@zip-kiel.de
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Kontakt:
- Seeck, MD
- Telefonnummer: +49 431 9900 2681
- E-mail: m.seeck-hirschner@zip-kiel.de
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Ledende efterforsker:
- Aldenhoff, MD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- DSM-IV -TR Diagnosis axis II: borderline personality disorder; axis I: posttraumatic stress disorder
- stable medication
- age 18-45 years, gender female
- legal competence
- sufficient cognitive function
- sufficient knowledge of the German or English language
Exclusion Criteria:
Known severe internal, neurological, musculoskeletal, endocrinological or sleep disorders with organic origin (clinical examination during the screening visit, judged by the investigator)
- gravidity (positive ß-HCG test)
- continuing and not interruptible exposure to sexual or physical abuse
- acute suicidal tendency
- positive drug-screening in urine toxicology test
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: treatment as usual
Treatment as usual
|
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
|
Eksperimentel: narrative exposure therapy
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
|
Narrative Exposure Therapy (NET), an evidence-based trauma-focussed treatment, suitable for survivors of prolonged and repeated exposure to traumatic stress and childhood adversities
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Clinician-Administered PTSD Scale (CAPS)
Tidsramme: 0 - 1 - 6 - 12 - 24 month
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0 - 1 - 6 - 12 - 24 month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Borderline symptom checklist 23 (BSL)
Tidsramme: 0 - 1 - 6 - 12 - 24
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0 - 1 - 6 - 12 - 24
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NET
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Kliniske forsøg med narrative exposure therapy
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Riphah International UniversityRekruttering
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Catalan Institute of HealthRekrutteringOverforbrugssyndromSpanien
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University of Mississippi, OxfordAfsluttetPosttraumatisk stresslidelse (PTSD)Forenede Stater
-
University of Colorado, DenverNational Institute of Nursing Research (NINR)AfsluttetHjertefejl | NyresvigtForenede Stater
-
University of KonstanzCentre for Psychiatry ReichenauUkendt
-
Icahn School of Medicine at Mount SinaiNational Cancer Institute (NCI)Afsluttet
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University of NottinghamNational Health Service, United KingdomAktiv, ikke rekrutterendeKræft | Traumatisk stresslidelseDet Forenede Kongerige
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Akron Children's HospitalRekruttering
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VA Office of Research and DevelopmentRekrutteringTraumatisk hjerneskade | Neurogene kommunikationsforstyrrelserForenede Stater
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University of ChicagoPlanned Parenthood Federation of AmericaAfsluttet