- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02069873
Effectiveness of Cognitive, Exposure, and Skills Group Manualized Treatments in Operations Iraqi (OIF)/Operation Enduring Freedom (OEF) Female Veterans
20. februar 2014 oppdatert av: Diane T. Castillo, Ph.D., New Mexico VA Healthcare System
Phase II Efficacy Study on Group Delivery of Effective Treatments for PTSD
The purpose of the study is to evaluate the efficacy of a group protocol for the delivery of evidence-based therapies in comparison to a wait-list control and evaluate the relative contribution of exposure, cognitive, and skills blocks of treatment in a 16-session manualized group treatment protocol in a sample of OIF/OEF female PTSD veterans.
Hyp1: Overall improvement is expected in PTSD symptoms compared to a wait-list control group; and Hyp2: the exposure and cognitive components are expected to show greater improvement in PTSD symptoms than the skills component.
Significant results will establish the efficacy of a group format for evidence-based treatments for all veterans with a PTSD diagnosis.
An ancillary part of the study is to examine initial neuropsychological presentation in this population and possible changes that may occur as the result of treatment.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES: The objectives are to 1) evaluate the effectiveness of exposure, cognitive, and skills (assertiveness/relaxation) therapies within a 16-session group; and 2) evaluate the relative contribution of each of three treatment components in a manualized treatment group in a sample of OIF/OEF female PTSD veterans.
HYPOTHESES: Hypothesis 1. Female OIF/OEF PTSD veterans will show reductions in PTSD symptoms and improvement in general functioning after participation in a structured group treatment compared to a wait-list control group.
Hypothesis 2. Exposure and cognitive components will show greater improvement in PTSD symptoms than the skills component.
RESEARCH DESIGN/BACKGROUND: Based on studies with male combat veterans, female civilian rape victims, and female veterans, therapies most effective for Posttraumatic Stress Disorder (PTSD) are exposure therapy (1,2,3) and cognitive restructuring (4), with less improvement found in other treatments, such as relaxation and assertiveness training (5).
Most examinations of PTSD treatments have been conducted in an individual format, but most PTSD treatments offered in Veterans Administration (VA) hospital PTSD programs are conducted in a group format (6).
It is critical to determine if these therapies work in a group setting, as only one study (7) found no differences in exposure therapy compared to a support group.
In a comprehensive manualized group treatment protocol (8) exposure therapy provided in a group was found effective (9).
The aim of the present study is to establish the effectiveness of exposure therapy, among other evidence-based therapies, in a well designed randomized study.
METHODOLOGY: Castillo's (8) manualized group treatment protocol for female veterans with PTSD will be modified into a 16-week treatment group with a five-week exposure, five-week cognitive, and four-week skills treatment blocks.
Seventy-two subjects will be assessed with structured interviews (SCID and CAPS) and questionnaires (Traumatic Life Events and Quality of Life Inventory) and randomized into one of two arms: 16-week immediate treatment, or a 16-week wait-list control, the latter of which will be reassessed and offered the study treatment.
Oversampling will result in 72 subjects in the active treatment arm.
Subjects will be reassessed upon completion of treatment or wait-list, at 3, and 6 months following treatment.
All treatment groups will include three female OIF/OEF veterans positive for PTSD.
The treatment blocks will be varied into six possible orders to control for order effects and the PTSD Symptom Checklist will be administered after each treatment block.
Data will be collected for three years.
CLINICAL RELATIONSHIPS: Significant results will contribute to the establishment of evidence-based treatments in a manualized treatment group for all veterans with a PTSD diagnosis.
FINDINGS: Present findings from Dr. Castillo's lab suggest the effectiveness of exposure therapy in a group setting.
Studietype
Intervensjonell
Registrering (Faktiske)
86
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87108
- New Mexico VA Health Care System
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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
19 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
Inclusion Criteria:
- Diagnosis of PTSD
- Iraq or Afghanistan female Veteran
- Psychiatry stability (no suicide, homicide)
- One clear memory of a trauma
- Stability on psychiatric medications for 1 month
Exclusion Criteria:
- Active substance use/abuse (or in remission less than 3 mo)
- Psychotic symptoms or diagnosis
- Bipolar disorder diagnosis
- Cognitive impairment
- Involvement in a violent relationship
- Self mutilation within past 6 months
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 |
|---|---|
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Eksperimentell: 16-Week Group Treatment
The 16-week treatment group will contain 3 blocks of treatment (exposure, cognitive, skills) with order randomized within the treatment.
The first and last group session are considered inactive treatment sessions.
The group treatment will be provided weekly.
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Within the 16-week group treatment, the cognitive block will contain 5 sessions, the exposure block will contain 5 sessions, and the skills block will contain 4 sessions.
Andre navn:
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Ingen inngripen: Wait List Control
The Wait List Control group will receive minimal attention, as they will meet bi-monthly for supportive sessions with the study psychologist.
The study psychologist will not introduce any active treatment in the individual sessions.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in PTSD from baseline on the Clinician Administered PTSD Scale (CAPS) to post-treatment, 3 months, and 6 months later.
Tidsramme: Baseline, post-treatment, 3 months follow up, 6 months follow up.
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Interview administration of the CAPS by independent assessor captures current (past month) and lifetime symptoms and diagnosis of Post-Traumatic Stress Disorder (PTSD).
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Baseline, post-treatment, 3 months follow up, 6 months follow up.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in mental and physical functioning from baseline on the Health Related Quality of Life (SF36) to post-treatment, 3 months, and 6 months later.
Tidsramme: Baseline, post-treatment, 3-month follow up, 6-month follow up
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Self-report questionnaire measures 8 life-functioning scales summarized by two content scales--Mental and Physical functioning.
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Baseline, post-treatment, 3-month follow up, 6-month follow up
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Change in quality of life from baseline on the Quality of Life Inventory (QOLI) to post-treatment, 3 months, and 6 months later.
Tidsramme: Baseline, post-treatment, 3-month follow up, 6-month follow up
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QOLI is a self-report questionnaire measuring overall quality of life across 16 domains.
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Baseline, post-treatment, 3-month follow up, 6-month follow up
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Change in PTSD from baseline to points during treatment with the PTSD Symptom Checklist (PCL).
Tidsramme: Baseline, after each treatment block (every 5 weeks), post-treatment
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The PCL is a self-report questionnaire measuring 17 PTSD symptoms.
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Baseline, after each treatment block (every 5 weeks), post-treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Diane T Castillo, Ph.D., New Mexico VA Healthcare System
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Foa EB, Rothbaum BO, Riggs DS, Murdock TB. Treatment of posttraumatic stress disorder in rape victims: a comparison between cognitive-behavioral procedures and counseling. J Consult Clin Psychol. 1991 Oct;59(5):715-23. doi: 10.1037//0022-006x.59.5.715.
- Schnurr PP, Friedman MJ, Engel CC, Foa EB, Shea MT, Chow BK, Resick PA, Thurston V, Orsillo SM, Haug R, Turner C, Bernardy N. Cognitive behavioral therapy for posttraumatic stress disorder in women: a randomized controlled trial. JAMA. 2007 Feb 28;297(8):820-30. doi: 10.1001/jama.297.8.820.
- Schnurr PP, Friedman MJ, Foy DW, Shea MT, Hsieh FY, Lavori PW, Glynn SM, Wattenberg M, Bernardy NC. Randomized trial of trauma-focused group therapy for posttraumatic stress disorder: results from a department of veterans affairs cooperative study. Arch Gen Psychiatry. 2003 May;60(5):481-9. doi: 10.1001/archpsyc.60.5.481.
- Keane TM , Fairbank JA , Caddell JM , Zimering RT : Implosive (flooding) therapy reduces symptoms of PTSD in Vietnam combat Veterans . Behav Ther 1989 ; 20: 245 - 60 .
- Resick PA, Schnicke MK. Cognitive processing therapy for sexual assault victims. J Consult Clin Psychol. 1992 Oct;60(5):748-56. doi: 10.1037//0022-006x.60.5.748.
- Cahill SP, Rothbaum BO, Resick P, & Follette VM. Cognitive-behavioral therapy for adults. In E. B. Foa, T. M. Keane, M. J. Friedman, & J. A. Cohen (Eds.), Effective treatments for PTSD: Practice Guidelines from the International Society for Traumatic Stress Studies (pp. 139-222). New York: The Guildford Press, 2009.
- Garrick J : Efficacy of PTSD treatment in the VA . VHSJ 2000 : 5: 15-21 .
- Castillo DT : Systematic outpatient treatment of sexual trauma in women: Application of cognitive and behavioral protocols . Cogn Behav Pract 2004 : 11: 352 - 65 .
- Castillo DT, C' de Baca J, Qualls C, Bornovalova MA. Group exposure therapy treatment for post-traumatic stress disorder in female veterans. Mil Med. 2012 Dec;177(12):1486-91. doi: 10.7205/milmed-d-12-00186.
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. april 2008
Primær fullføring (Faktiske)
1. februar 2013
Studiet fullført (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først innsendt
14. februar 2014
Først innsendt som oppfylte QC-kriteriene
20. februar 2014
Først lagt ut (Anslag)
24. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. februar 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- W81XWH-08-2-0022
- PT074309 (Annet stipend/finansieringsnummer: Department of Defense)
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