SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00265564
First received: December 13, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes.


Condition Intervention
Substance Use Disorders
Posttraumatic Stress Disorder
Behavioral: Modified Seeking Safety integrated into std outpatient SUD care
Behavioral: Standard outpatient SUD care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness of Screening and Treatment for PTSD in SUD Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Severity of drug & alcohol use (ASI drug and alcohol composite scores), [ Time Frame: The ASI is administered at baseline and 3 months, 6 months and 12 months post baseline. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PTSD symptoms (IES total score), drug craving (Brief Substance Craving Questionnaire), mental health status (SF-36V), social functioning (SF-36V), legal problems (ASI legal composite), treatment satisfaction (CSQ-8) [ Time Frame: All secondary outcome measures, with the exception of the CSQ-8, are administered at baseline and 3 months, 6 months and 12 months post enrollment. The CSQ-8 is administered at 3 months, 6 months and 12 months post enrollment. ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: July 2006
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Seeking Safety is a manualized, empirically supported, cognitive behavioral therapy that treats substance use disorders and comorbid PTSD. Participants assigned to the Seeking Safety arm attend two one hour sessions of group therapy for 12 weeks.
Behavioral: Modified Seeking Safety integrated into std outpatient SUD care
The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
Other Name: Seeking Safety
Active Comparator: Arm 2
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Behavioral: Standard outpatient SUD care
Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.

Detailed Description:

Background: This study proposes a prospective program of research that will identify feasible and inexpensive methods to detect and treat comorbid PTSD among VA SUD patients, thereby improving substance abuse treatment outcomes.

Objective(s): Our objectives are to test the effectiveness of substituting 2 hours/week of Seeking Safety-based groups for standard substance use focused groups for male patients attending outpatient substance use disorder treatment who meet clinical criteria for PTSD. Primary outcomes measures will assess substance use disorder severity and secondary outcome measures will assess mental health and substance use related problems plus treatment satisfaction. We hypothesize that enhanced SUD treatment that incorporates "Seeking Safety" will improve SUD treatment outcomes for PTSD-SUD patients as compared to outcomes for PTSD-SUD patients receiving treatment as usual. Additionally, we examine two hypothesized models via which "Seeking Safety" may effect substance use outcomes. We examine whether 1) reductions in PTSD symptomatology and 2) improvements in coping strategies used in response to PTSD symptoms (reductions in using to cope and other avoidance coping strategies) partially mediate the effect of treatment on substance use outcomes.

Methods: This is a randomized clinical trial of 210 male veterans with PTSD and substance use disorders attending outpatient substance use disorder treatment at the VA Oakland mental health center. Patients will be randomized to 3 months of outpatient substance abuse treatment including either 2 hours/week of "Seeking Safety" or standard addiction focused group therapy. Data will be collected in patient interviews at treatment entry and at 3, 6 and 12 months after treatment initiation and by medical record review. Substance use, PTSD symptomatology, mental health, social functioning, legal problems, use of coping techniques, and treatment satisfaction outcomes will be assessed at treatment entry and 3, 6 and 12 months later using well-validated survey instruments. Primary and secondary treatment outcomes of patients in "Seeking Safety" versus treatment as usual will be compared by repeated measures ANCOVA. We will test the mediational hypotheses according to the 4-step method described by Baron and Kenny (1986).

Status: Project began in January, 2006; Recruitment is complete. Treatment and assessment is ongoing.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. veteran status and VA healthcare eligibility,
  2. a diagnosis of any alcohol or drug use disorder,
  3. having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and
  4. meeting criteria for a PTSD diagnosis based on a preliminary screen with the PC-PTSD and subsequent full clinical evaluation using the CAPS

Exclusion Criteria:

  1. current participation in any day or inpatient mental health treatment,
  2. any contraindications communicated by that patient's primary clinician,
  3. acute psychosis, mania, dementia, or suicidal intent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265564

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
Investigators
Principal Investigator: Jodie A. Trafton, PhD VA Palo Alto Health Care System
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00265564     History of Changes
Other Study ID Numbers: IIR 04-175
Study First Received: December 13, 2005
Last Updated: April 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
outcomes assessment
substance use disorders
stress disorders, post-traumatic
screening

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014