- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00057629
Prolonged Exposure Therapy for Post Traumatic Stress Disorder Following Sexual Assault
Effectiveness of Treatment for PTSD in Community Agencies
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Center for the Treatment and Study of Anxiety, University of Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Women Organized Against Rape (WOAR)
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
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: 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.
|
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. |
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.
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Severity of PTSD, depression, anxiety and general function
Tidsramme: Measured pre- and post-treatment
|
Measured pre- and post-treatment
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Elizabeth A Hembree, PhD, University of Pennsylvania Faculty
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH042178 (U.S. NIH-bevilling/kontrakt)
- DSIR AT-AS
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Prolonged Exposure (PE)
-
University of ZurichBeijing Normal University; Jichi Medical UniversityTrukket tilbage
-
VA Office of Research and DevelopmentAfsluttetPosttraumatiske stresslidelser | Kronisk søvnløshedForenede Stater
-
VA Office of Research and DevelopmentDefense Centers of Excellence for Psychological Health and Traumatic...RekrutteringPost traumatisk stress syndromForenede Stater
-
Harvard School of Public Health (HSPH)Judge Baker Children's CenterAfsluttetStemningsforstyrrelser | Angstlidelser | Opmærksomhedsunderskud og forstyrrende adfærdsforstyrrelser | Autistisk lidelse | Adfærdsforstyrrelse | Oppositionel Defiant DisorderForenede Stater
-
University of BergenHaukeland University Hospital; Bergen University CollegeAfsluttet
-
Medical University of South CarolinaGeorgia State UniversityAfsluttetAngstlidelser | Stresslidelser, posttraumatisk | Psykisk lidelse | Traumatisk stresslidelseForenede Stater
-
Oslo University HospitalAfsluttet
-
Research Foundation for Mental Hygiene, Inc.University of Colorado, Boulder; Harvard UniversityAfsluttetPosttraumatisk stresslidelse (PTSD)Forenede Stater
-
VA Office of Research and DevelopmentAfsluttet
-
University of MichiganMichigan Department of Health and Human ServicesAfsluttet