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Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder

2. maj 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02459
        • VA Boston Healthcare System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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: Seeking Safety (SS)
17 sessions of present-focused therapy Seeking Safety
Adfærdsmæssigt: Seeking Safety (SS)
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.
Eksperimentel: Creating Change (CC)
17 sessions of past-focused Creating Change
Adfærdsmæssigt: Creating Change (CC)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

VA Boston Healthcare System

Efterforskere

  • Ledende efterforsker: Karen E. Krinsley, Ph.D., VA Boston Healthcare System
  • Ledende efterforsker: Lisa M Najavits, PhD, VA Boston Healthcare System

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

10. januar 2011

Først indsendt, der opfyldte QC-kriterier

10. januar 2011

Først opslået (Skøn)

11. januar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SPLA-CX000308-01 (VA CSRD)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Kliniske forsøg med Seeking Safety (SS)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner