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

Posttraumatic Stress Disorder Clinical Trial

Official title:

Effectiveness of Screening and Treatment for PTSD in SUD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265564
• Other study ID #: IIR 04-175
• Status: Completed
• Phase: N/A
• Start date: July 2006
• Est. completion date: July 2011

Study information

• Verified date: August 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Standard outpatient SUD care
Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (8)

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: — View 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. — View 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 — View 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. — View 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. — View 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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Administered at baseline and 3 months, 6 months and 12 months post baseline.
Primary	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).	1 year
Secondary	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)	Administered at 3 months, 6 months and 12 months post enrollment