- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01274741
Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
2. mai 2019 oppdatert av: Karen Krinsley, VA Boston Healthcare System
Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD.
CC helps clients explore the past as a step in their recovery process.
It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings.
It has particular relevance for VA in that many veterans suffer from PTSD and SUD.
The new model demonstrated positive results in two pilot studies.
Studietype
Intervensjonell
Registrering (Faktiske)
52
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02459
- VA Boston Healthcare System
-
-
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 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder
- Have used a substance in the 60 days prior to intake
- Outpatient
- Plan to stay in Boston for the next 6 months
- If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study
- Have a stable mailing address and live nearby enough to come to VA Boston for treatment
- Able to sign informed consent
- Willing to participate in all assessments and urine testing
- Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns
Exclusion Criteria:
- Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning
- Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder
- Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated
- Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months)
- The patient is mandated to treatment
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: Seeking Safety (SS)
17 sessions of present-focused therapy Seeking Safety
|
Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD.
It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders.
In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.
|
Eksperimentell: Creating Change (CC)
17 sessions of past-focused Creating Change
|
Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD.
It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format.
The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
PTSD symptoms assessed via self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
PTSD diagnosis as assessed by a trained interviewer
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Alcohol use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Drug use and associated problems as measured by blinded-interviewer measure Composite.
These outcome variables will be measured at baseline, end of treatment and 3-month followup.
Urinanlysis/breathalyzer will be obtained to verify ASI self-report.
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
Tidsramme: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Self-report measure
|
Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Karen E. Krinsley, Ph.D., VA Boston Healthcare System
- Hovedetterforsker: Lisa M Najavits, PhD, VA Boston 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.
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 2011
Primær fullføring (Faktiske)
1. mars 2015
Studiet fullført (Faktiske)
1. mars 2015
Datoer for studieregistrering
Først innsendt
10. januar 2011
Først innsendt som oppfylte QC-kriteriene
10. januar 2011
Først lagt ut (Anslag)
11. januar 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. mai 2019
Sist bekreftet
1. mai 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SPLA-CX000308-01 (VA CSRD)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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 Seeking Safety (SS)
-
Treatment InnovationsNational Institute on Drug Abuse (NIDA); National Institutes of Health...FullførtPTSD | Traume | Rusmisbruksforstyrrelser | Emosjonell dysfunksjonForente stater
-
VA Office of Research and DevelopmentFullførtRusmisbruksforstyrrelser | Posttraumatisk stresslidelseForente stater
-
Johns Hopkins UniversityAmerican SIDS InstituteHar ikke rekruttert ennåPlutselig spedbarnsdød
-
Smiths Medical, ASD, Inc.FullførtPerifert intravenøst kateterCanada
-
Surgify Medical OyFullførtKirurgi | RyggkirurgiFinland
-
Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... og andre samarbeidspartnerePåmelding etter invitasjonInfeksjoner | Mors sepsisForente stater
-
Peking Union Medical College HospitalRekruttering
-
M.D. Anderson Cancer CenterRekrutteringOnkologiske komplikasjoner og nødsituasjonerForente stater
-
Ottawa Hospital Research InstituteHar ikke rekruttert ennåForverring, kliniskCanada