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 18, 2013
Last verified: September 2011

December 13, 2005
April 18, 2013
July 2006
April 2011   (final data collection date for primary outcome measure)
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 ]
severity of drug & alcohol use (ASI drug and alcohol composite scores),
Complete list of historical versions of study NCT00265564 on ClinicalTrials.gov Archive Site
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 ]
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)
Not Provided
Not Provided
 
SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)
Effectiveness of Screening and Treatment for PTSD in SUD Patients

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Substance Use Disorders
  • Posttraumatic Stress Disorder
  • 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
  • Behavioral: Standard outpatient SUD care
    Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
  • 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.
    Intervention: Behavioral: Modified Seeking Safety integrated into std outpatient SUD care
  • Active Comparator: Arm 2
    Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
    Intervention: Behavioral: Standard outpatient SUD care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
July 2011
April 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00265564
IIR 04-175
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Jodie A. Trafton, PhD VA Palo Alto Health Care System
Department of Veterans Affairs
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP