Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265564
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2005-12-13
Brief Title:
SUPER Study Substance Use and PTSD Treatment Effectiveness Research Study
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effectiveness of Screening and Treatment for PTSD in SUD Patients
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Objectives Our objectives are to test the effectiveness of substituting 2 hoursweek 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 hoursweek 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
Objectives Our objectives are to test the effectiveness of substituting 2 hoursweek 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 hoursweek 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None