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

Primary Purpose

Substance Use Disorders, Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Seeking Safety integrated into std outpatient SUD care
Standard outpatient SUD care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Substance Use Disorders focused on measuring outcomes assessment, substance use disorders, stress disorders, post-traumatic, screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: veteran status and VA healthcare eligibility, a diagnosis of any alcohol or drug use disorder, having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and 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: current participation in any day or inpatient mental health treatment, any contraindications communicated by that patient's primary clinician, acute psychosis, mania, dementia, or suicidal intent

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Seeking Safety

Usual Care

Arm Description

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.

Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.

Outcomes

Primary Outcome Measures

Severity of Alcohol Use (ASI Alcohol Composite Scores)
Alcohol and drug use composite scores were separately analyzed. The ASI alcohol composite score measures the severity of substance use and amount of use in the past 30 days and consequences of use. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
ASI Drug Composite Score
Addiction Severity Index (ASI) drug composite scores measure past 30 days substance use (McLellan et al., 1992). The ASI assesses lifetime and current use of all major classes of drugs of abuse, history of substance-related problems, and history of SUD treatment. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).

Secondary Outcome Measures

PTSD Symptoms (IES Total Score)
Composite measures of PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranging from 0 (not at all) to 88 (extremely)

Full Information

First Posted
December 13, 2005
Last Updated
August 19, 2020
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00265564
Brief Title
SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)
Official Title
Effectiveness of Screening and Treatment for PTSD in SUD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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, treatment and assessment is complete and primary trial finds are published. Secondary analysis is ongoing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Posttraumatic Stress Disorder
Keywords
outcomes assessment, substance use disorders, stress disorders, post-traumatic, screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seeking Safety
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Intervention Type
Behavioral
Intervention Name(s)
Modified Seeking Safety integrated into std outpatient SUD care
Other Intervention Name(s)
Seeking Safety
Intervention Description
The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Standard outpatient SUD care
Intervention Description
Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
Primary Outcome Measure Information:
Title
Severity of Alcohol Use (ASI Alcohol Composite Scores)
Description
Alcohol and drug use composite scores were separately analyzed. The ASI alcohol composite score measures the severity of substance use and amount of use in the past 30 days and consequences of use. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
Time Frame
Administered at baseline and 3 months, 6 months and 12 months post baseline.
Title
ASI Drug Composite Score
Description
Addiction Severity Index (ASI) drug composite scores measure past 30 days substance use (McLellan et al., 1992). The ASI assesses lifetime and current use of all major classes of drugs of abuse, history of substance-related problems, and history of SUD treatment. Scored as values between 0 and 1 with higher values indicating more severe substance use (i.e. lower values indicate a better outcome).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
PTSD Symptoms (IES Total Score)
Description
Composite measures of PTSD symptoms. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total score ranging from 0 (not at all) to 88 (extremely)
Time Frame
Administered at 3 months, 6 months and 12 months post enrollment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: veteran status and VA healthcare eligibility, a diagnosis of any alcohol or drug use disorder, having completed an intake for outpatient SUD treatment at the VA Oakland outpatient mental health clinic, and 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: current participation in any day or inpatient mental health treatment, any contraindications communicated by that patient's primary clinician, acute psychosis, mania, dementia, or suicidal intent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jodie A. Trafton, PhD
Organizational Affiliation
VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1290
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17602023
Citation
Weaver CM, Trafton JA, Walser RD, Kimerling RE. Pilot test of seeking safety treatment with male veterans. Psychiatr Serv. 2007 Jul;58(7):1012-3. doi: 10.1176/ps.2007.58.7.1012. No abstract available.
Results Reference
result
PubMed Identifier
21923756
Citation
Boden MT, Kimerling R, Jacobs-Lentz J, Bowman D, Weaver C, Carney D, Walser R, Trafton JA. Seeking Safety treatment for male veterans with a substance use disorder and post-traumatic stress disorder symptomatology. Addiction. 2012 Mar;107(3):578-86. doi: 10.1111/j.1360-0443.2011.03658.x.
Results Reference
result
PubMed Identifier
22115887
Citation
Oliva EM, Harris AH, Trafton JA, Gordon AJ. Receipt of opioid agonist treatment in the Veterans Health Administration: facility and patient factors. Drug Alcohol Depend. 2012 May 1;122(3):241-6. doi: 10.1016/j.drugalcdep.2011.10.004. Epub 2011 Nov 23.
Results Reference
result
PubMed Identifier
24073081
Citation
Midboe AM, Cucciare MA, Trafton JA, Ketroser N, Chardos JF. Implementing motivational interviewing in primary care: the role of provider characteristics. Transl Behav Med. 2011 Dec;1(4):588-94. doi: 10.1007/s13142-011-0080-9.
Results Reference
result
PubMed Identifier
22549276
Citation
Harris AH, Oliva E, Bowe T, Humphreys KN, Kivlahan DR, Trafton JA. Pharmacotherapy of alcohol use disorders by the Veterans Health Administration: patterns of receipt and persistence. Psychiatr Serv. 2012 Jul;63(7):679-85. doi: 10.1176/appi.ps.201000553.
Results Reference
result
PubMed Identifier
24854218
Citation
Tyler Boden M, Kimerling R, Kulkarni M, Bonn-Miller MO, Weaver C, Trafton J. Coping among military veterans with PTSD in substance use disorder treatment. J Subst Abuse Treat. 2014 Aug;47(2):160-7. doi: 10.1016/j.jsat.2014.03.006. Epub 2014 Apr 13.
Results Reference
result
PubMed Identifier
27480546
Citation
Zimmerman L, Lounsbury DW, Rosen CS, Kimerling R, Trafton JA, Lindley SE. Participatory System Dynamics Modeling: Increasing Stakeholder Engagement and Precision to Improve Implementation Planning in Systems. Adm Policy Ment Health. 2016 Nov;43(6):834-849. doi: 10.1007/s10488-016-0754-1. Erratum In: Adm Policy Ment Health. 2021 Mar;48(2):377.
Results Reference
result
PubMed Identifier
28714721
Citation
Kearney LK, Smith C, Kivlahan DR, Gresen RC, Moran E, Schohn M, Trafton J, Zeiss AM. Mental health productivity monitoring in the Veterans Health Administration: Challenges and lessons learned. Psychol Serv. 2018 Nov;15(4):486-495. doi: 10.1037/ser0000173. Epub 2017 Jul 17.
Results Reference
result

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

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