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

Alcohol Use Disorder Clinical Trial

Official title:

Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274741
• Other study ID #: SPLA-CX000308-01 (VA CSRD)
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: March 2015

Study information

• Verified date: May 2019
• Source: VA Boston Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1080/10826084.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup	PTSD symptoms assessed via self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Primary	Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment 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
Primary	Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment 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
Primary	Change in Addiction Severity Index drug composite score - from baseline through end of treatment 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
Secondary	Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary	Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary	Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary	Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary	Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary	Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup
Secondary	Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup	Self-report measure	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup