Trial Outcomes & Findings for SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study) (NCT NCT00265564)
NCT ID: NCT00265564
Last Updated: 2020-09-07
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
Administered at baseline and 3 months, 6 months and 12 months post baseline.
Results posted on
2020-09-07
Participant Flow
Participant milestones
| Measure |
Seeking Safety
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.
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.
|
Usual Care
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
Seeking Safety
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.
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.
|
Usual Care
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
|
Overall Study
met exclusion criteria
|
5
|
2
|
Baseline Characteristics
SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)
Baseline characteristics by cohort
| Measure |
Seeking Safety
n=49 Participants
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.
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.
|
Usual Care
n=49 Participants
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.30 years
STANDARD_DEVIATION 9.38 • n=5 Participants
|
53.01 years
STANDARD_DEVIATION 9.96 • n=7 Participants
|
54.13 years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Administered at baseline and 3 months, 6 months and 12 months post baseline.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).
Outcome measures
| Measure |
Seeking Safety
n=49 Participants
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.
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.
|
Usual Care
n=49 Participants
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
|
|---|---|---|
|
Severity of Alcohol Use (ASI Alcohol Composite Scores)
Baseline
|
.259 units on a scale
Standard Deviation .264
|
.225 units on a scale
Standard Deviation .237
|
|
Severity of Alcohol Use (ASI Alcohol Composite Scores)
3 months
|
.169 units on a scale
Standard Deviation .191
|
.152 units on a scale
Standard Deviation .129
|
|
Severity of Alcohol Use (ASI Alcohol Composite Scores)
6 months
|
.138 units on a scale
Standard Deviation .173
|
.141 units on a scale
Standard Deviation .146
|
|
Severity of Alcohol Use (ASI Alcohol Composite Scores)
12 months
|
.149 units on a scale
Standard Deviation .168
|
.134 units on a scale
Standard Deviation .137
|
PRIMARY outcome
Timeframe: 1 yearAddiction 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).
Outcome measures
| Measure |
Seeking Safety
n=49 Participants
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.
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.
|
Usual Care
n=49 Participants
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
|
|---|---|---|
|
ASI Drug Composite Score
Baseline
|
.089 units on a scale
Standard Deviation .080
|
.106 units on a scale
Standard Deviation .084
|
|
ASI Drug Composite Score
3 months
|
.057 units on a scale
Standard Deviation .062
|
.095 units on a scale
Standard Deviation .091
|
|
ASI Drug Composite Score
6 months
|
.051 units on a scale
Standard Deviation .060
|
.088 units on a scale
Standard Deviation .091
|
|
ASI Drug Composite Score
12 months
|
.046 units on a scale
Standard Deviation .053
|
.066 units on a scale
Standard Deviation .062
|
SECONDARY outcome
Timeframe: Administered at 3 months, 6 months and 12 months post enrollmentComposite 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)
Outcome measures
| Measure |
Seeking Safety
n=49 Participants
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.
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.
|
Usual Care
n=49 Participants
Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment.
Standard outpatient SUD care: Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
|
|---|---|---|
|
PTSD Symptoms (IES Total Score)
Baseline
|
46.76 units on a scale
Standard Deviation 19.49
|
47.66 units on a scale
Standard Deviation 16.26
|
|
PTSD Symptoms (IES Total Score)
12 months
|
35.26 units on a scale
Standard Deviation 20.44
|
34.07 units on a scale
Standard Deviation 17.72
|
|
PTSD Symptoms (IES Total Score)
3 months
|
40.80 units on a scale
Standard Deviation 20.86
|
42.40 units on a scale
Standard Deviation 21.30
|
|
PTSD Symptoms (IES Total Score)
6 months
|
38.90 units on a scale
Standard Deviation 16.72
|
36.47 units on a scale
Standard Deviation 16.94
|
Adverse Events
Seeking Safety
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jodie Trafton, Director Program Evaluation and Resource Center
Office of Mental Health Operation, Veterans Health Administration
Phone: 650-493-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place