Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
2 mai 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
52
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02459
- VA Boston Healthcare System
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Seeking Safety (SS)
17 sessions of present-focused therapy Seeking Safety
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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.
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Expérimental: Creating Change (CC)
17 sessions of past-focused Creating Change
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD symptoms assessed via self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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PTSD diagnosis as assessed by a trained interviewer
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
|
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Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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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.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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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.
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
Délai: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Self-report measure
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Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Karen E. Krinsley, Ph.D., VA Boston Healthcare System
- Chercheur principal: Lisa M Najavits, PhD, VA Boston Healthcare System
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2011
Achèvement primaire (Réel)
1 mars 2015
Achèvement de l'étude (Réel)
1 mars 2015
Dates d'inscription aux études
Première soumission
10 janvier 2011
Première soumission répondant aux critères de contrôle qualité
10 janvier 2011
Première publication (Estimation)
11 janvier 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 mai 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 mai 2019
Dernière vérification
1 mai 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SPLA-CX000308-01 (VA CSRD)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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