Substance Use DisordersNCT00265564
SUPER Study (Substance Use and PTSD Treatment Effectiveness Research Study)
A study testing Modified Seeking Safety integrated into std outpatient SUD care and Standard outpatient SUD care in people with Substance Use Disorders and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Use Disorders, Posttraumatic Stress Disorder
- What is being tested?
- Modified Seeking Safety integrated into std outpatient SUD care and Standard outpatient SUD care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
About this study
Official title: 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.
Read the 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.
- Being tested
- Modified Seeking Safety integrated into std outpatient SUD care, Standard outpatient SUD care
- Keywords
- outcomes assessment, substance use disorders, stress disorders, post-traumatic, screening
- Medical subject headings
- Substance-Related Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Seeking Safety integrated into std outpatient SUD careBehavioural
Also called Seeking Safety
The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.
Standard outpatient SUD careBehavioural
Patients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence.
| Study group | Role | What they receive |
|---|---|---|
| Seeking Safety | Active comparator | 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. Receives: Behavioral: Modified Seeking Safety integrated into std outpatient SUD care |
| Usual Care | Active comparator | Usual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment. Receives: Behavioral: Standard outpatient SUD care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Administered at baseline and 3 months, 6 months and 12 months post baseline.
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).
Measured: 1 year
Secondary outcomes (1)
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)
Measured: Administered at 3 months, 6 months and 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2005 (estimated)
- Study startJul 2006
- Primary completionApr 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jodie A. Trafton, PhD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265564
- Sponsor's protocol ID
- IIR 04-175
- Status last verified
- Aug 2020
- First submitted
- 13 Dec 2005
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17602023Boden 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.
PubMed 21923756Oliva 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.
PubMed 22115887Midboe 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.
PubMed 24073081Harris 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.
PubMed 22549276Tyler 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.
PubMed 24854218Zimmerman 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.
PubMed 27480546Kearney 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.
PubMed 28714721
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Screening and Treatment for PTSD in SUD Patients
- ClinicalTrials.gov ID
- NCT00265564
- Acronym / sponsor ID
- IIR 04-175
- Keywords
- outcomes assessment, substance use disorders, stress disorders, post-traumatic, screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2006 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 14 Dec 2005 (estimated)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seeking Safety | Active comparator | Behavioral: Modified Seeking Safety integrated into std outpatient SUD careSeeking 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 | Active comparator | Behavioral: Standard outpatient SUD careUsual Care Condition. Patients randomized to usual care will receive standard outpatient SUD treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Seeking Safety integrated into std outpatient SUD careAlso: Seeking SafetyThe Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks. | Behavioural | Seeking Safety |
| Standard outpatient SUD carePatients assigned to standard care meet twice weekly in "Recovery 1" groups, which focuses on building abstinence. | Behavioural | Usual Care |
Primary outcome
Severity of Alcohol Use (ASI Alcohol Composite Scores)
Time frame: 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).
ASI Drug Composite Score
Time frame: 1 year
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 secondary outcome
PTSD Symptoms (IES Total Score)
Time frame: Administered at 3 months, 6 months and 12 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17602023Weaver 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 publication: PubMed 21923756Boden 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 publication: PubMed 22115887Oliva 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 publication: PubMed 24073081Midboe 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 publication: PubMed 22549276Harris 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 publication: PubMed 24854218Tyler 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 publication: PubMed 27480546Zimmerman 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.
- Results publication: PubMed 28714721Kearney 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodie A. Trafton, PhD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Seeking Safety integrated into std outpatient SUD care and Standard outpatient SUD care in people with Substance Use Disorders and Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Alcohol Use (ASI Alcohol Composite Scores) (time frame: Administered at baseline and 3 months, 6 months and 12 months post baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00265564, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.