NCT00265564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

August 1, 2020

Enrollment Period

4.8 years

First QC Date

December 13, 2005

Results QC Date

April 23, 2015

Last Update Submit

August 19, 2020

Conditions

Substance Use DisordersPosttraumatic Stress Disorder

Keywords

outcomes assessmentsubstance use disordersstress disorders, post-traumaticscreening

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

  • PTSD Symptoms (IES Total Score)

    Administered at 3 months, 6 months and 12 months post enrollment

Study Arms (2)

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.

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.

Behavioral: Standard outpatient SUD care

Interventions

Modified Seeking Safety integrated into std outpatient SUD careBEHAVIORAL

The Seeking Safety treatment involves two (one hour) sessions of manualized group therapy for 12 weeks.

Also known as: Seeking Safety
Seeking Safety
Standard outpatient SUD careBEHAVIORAL

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

Usual Care

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

Related Publications (8)

  • 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.

    PMID: 17602023RESULT

  • 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.

    PMID: 21923756RESULT

  • 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.

    PMID: 22115887RESULT

  • 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.

    PMID: 24073081RESULT

  • 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.

    PMID: 22549276RESULT

  • 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.

    PMID: 24854218RESULT

  • 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.

    PMID: 27480546RESULT

  • 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.

    PMID: 28714721RESULT

MeSH Terms

Conditions

Substance-Related DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Results Point of Contact

Title
Jodie Trafton, Director Program Evaluation and Resource Center
Organization
Office of Mental Health Operation, Veterans Health Administration
Jodie.Trafton@va.gov
650-493-5000

Study Officials

  • Jodie A. Trafton, PhD

    VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

July 1, 2006

Primary Completion

April 1, 2011

Study Completion

July 1, 2011

Last Updated

September 7, 2020

Results First Posted

September 7, 2020

Record last verified: 2020-08

Locations

US(1)