VA Boston Healthcare System
Boston, Massachusetts, 02459, United States
NCT Number: NCT01274741
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02459, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
PTSD symptoms assessed via self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
PTSD diagnosis as assessed by a trained interviewer
Time frame: 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.
Time frame: 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.
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
Time frame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Self-report measure
VA Boston Healthcare System
Fed
Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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