Clinical trial NCT01274741: Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder
Official title: Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Substance Use Disorder
Alcohol Use Disorder
Keywords: Posttraumatic stress disorder
Substance use disorder
Treatment efficacy
Randomized trial
Trauma
Substance abuse
Addiction
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2011-01-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary outcomes:
measure: Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
measure: Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup
timeFrame: Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: Karen E. Krinsley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Boston Healthcare System
name: Lisa M Najavits, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Najavits LM, Krinsley K, Waring ME, Gallagher MW, Skidmore C. A Randomized Controlled Trial for Veterans with PTSD and Substance Use Disorder: Creating Change versus Seeking Safety. Subst Use Misuse. 2018 Sep 19;53(11):1788-1800. doi: 10.1080/10826084.2018.1432653. Epub 2018 Feb 20.