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Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault

12. november 2015 oppdatert av: University of Pennsylvania

Effectiveness of Treatment for PTSD in Community Agencies

This study will evaluate the effectiveness of a brief cognitive behavioral therapy, administered by community agencies, for the treatment of patients with Post Traumatic Stress Disorder (PTSD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PE is a brief cognitive behavioral therapy that can ameliorate symptoms of PTSD, depression, and anxiety in survivors of various types of trauma. PE has been successfully implemented by counselors at a community rape crisis clinic (Women Organized Against Rape [WOAR]) who received extensive training and weekly supervision from PE experts. Such extensive expert involvement is not a practical model for long-term clinical practice in a community-based clinic. Therefore, Part 1 of this study will examine whether counselors at WOAR can maintain their PE implementation success with reduced expert involvement. In Part 2 of this study, PE will be implemented by counselors at another community clinic (Joseph J. Peters Institute [JJPI]) to examine its effectiveness in treating PTSD and to determine the generalizability of training procedures.

Participants in this study are randomly assigned to either PE or to individual and group therapy. Treatment sessions are conducted weekly for 10 to 20 weeks, based on participants' rates of improvement. Participants are assessed before treatment, after 10 weeks, and again in the follow-up phase at 3, 6, 12, and 24 months post-treatment.

Studietype

Intervensjonell

Registrering (Faktiske)

187

Fase

  • Fase 2
  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Center for the Treatment and Study of Anxiety, University of Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Women Organized Against Rape (WOAR)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 67 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • DSM-IV criteria for PTSD at least 12 weeks after sexual assault
  • PTSD symptoms that result from sexual assault and not from another traumatic experience

Exclusion Criteria:

  • DSM-IV criteria for schizophrenia or delusional disorder
  • Unstable bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment. Clients who are medicated and still meet current criteria for these disorders will be excluded.
  • Substance dependence
  • Continued intimate relationship with the assailant

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 1 Prolonged Exposure
Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
Atferdsmessig: Prolonged Exposure (PE)
Prolonged Exposure (PE) consists of 10 weekly 90-minute treatment sessions, which may be extended up to 20 sessions, depending on client response. Treatment procedures include education about common reactions to trauma, breathing retraining, prolonged (repeated) exposure to trauma memories, repeated in vivo exposure to situations the client is avoiding due to trauma-related fear, and discussion of thoughts and feelings related to exposure exercises as well as beliefs about self and the world.
Aktiv komparator: 2 Individual and group therapy

TUGT (Treatment as usual group therapy - used in Study 1), delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is no formal, structured format for these groups; counselors are sensitive to the participants' needs and follow their lead re content covered in discussions and exercises.

Supportive counseling (SC - study 2): individual therapy delivered in 10 weekly, 90 minute sessions. Therapist helps patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these.
Atferdsmessig: Treatment as usual group therapy (TUGT)
TUGT is delivered in ten weekly sessions, with 5 to 7 members and two counselors per group. There is not a formal, structured format for these groups; the counselors are sensitive to the participants' needs and follow their lead in terms of content covered in discussions and exercises. TUGT is conceptualized as supportive counseling and is based on the idea that members gain social support and information from one another.
Atferdsmessig: Supportive counseling (SC)
Supportive counseling is an individual therapy delivered in 10 weekly, 90 minute sessions. During this treatment, the therapist helps the patient identify daily stresses that may or may not be related to traumatic events and discusses them in a supportive non-directive mode with a problem-solving orientation. The therapist uses active listening, encouragement of expression of feelings, praise, and encouragement. The goal of this present-focused treatment is to provide support and to help the client to identify problems and stresses of daily living and to help her cope with these. No instructions for exposure are given.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Severity of PTSD, depression, anxiety and general function
Tidsramme: Measured pre- and post-treatment
Measured pre- and post-treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Pennsylvania

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Etterforskere

  • Hovedetterforsker: Elizabeth A Hembree, PhD, University of Pennsylvania Faculty

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2002

Primær fullføring (Faktiske)

1. august 2008

Studiet fullført (Faktiske)

1. august 2009

Datoer for studieregistrering

Først innsendt

4. april 2003

Først innsendt som oppfylte QC-kriteriene

4. april 2003

Først lagt ut (Anslag)

8. april 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. november 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. november 2015

Sist bekreftet

1. november 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R01MH042178 (U.S. NIH-stipend/kontrakt)
  • DSIR AT-AS

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Stresslidelser, posttraumatisk

Kliniske studier på Prolonged Exposure (PE)

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Sponsorer og samarbeidspartnere

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Forhold

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