Clinical trial NCT00078156: Women's Treatment for Trauma and Substance Use Disorders - 1
Official title: Women's Treatment for Trauma and Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Keywords: behavioral intervention
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2004-02-23
Enrollment: 409
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.


Eligibility criteria: Inclusion Criteria - Women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD.

Exclusion Criteria:

- Women will be excluded from the study who have current psychotic disorders, or a history of active psychosis (past two months); women with a diagnosis of substance abuse or dependence who also have either full or sub-threshold DSM-IV PTSD; and women who have current psychotic disorders, or a history of active psychosis (past two months).

Primary outcomes:
measure: Drug abstinence
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Gateway Community Services
state: Florida
city: Miami
country: United States
facility: The Villiage
state: Florida
city: Brooklyn
country: United States
facility: Addiction Research & Treatment Corp.-MSUCAS
state: New York
city: Brooklyn
country: United States
facility: Addiction Research & Treatment Corp.-RISE
state: New York
city: Columbus
country: United States
facility: Maryhaven, Inc.
state: Ohio
city: Charleston
country: United States
facility: Charleston Center
state: South Carolina
city: Kirkland
country: United States
facility: Residence XII
state: Washington
Study officials:
affiliation: New York State Psychiatric Institute
name: Denise Hien, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzpatrick SS, Morgan-Lopez AA, Saraiya TC, Back SE, Killeen TK, Norman SB, Lopez-Castro T, Ruglass LM, Saavedra LM, Hien DA. Graded response item response theory in scaling suicidal thoughts and behaviors among trauma-exposed women with substance use disorders. Psychol Addict Behav. 2022 Jun;36(4):397-409. doi: 10.1037/adb0000757. Epub 2021 Jun 17.
citation: Saavedra LM, Morgan-Lopez AA, Hien DA, Killeen TK, Back SE, Ruglass LM, Fitzpatrick S, Lopez-Castro T. Putting the Patient Back in Clinical Significance: Moderated Nonlinear Factor Analysis for Estimating Clinically Significant Change in Treatment for Posttraumatic Stress Disorder. J Trauma Stress. 2021 Apr;34(2):454-466. doi: 10.1002/jts.22624. Epub 2020 Nov 11.
citation: Ruglass LM, Morgan-Lopez AA, Saavedra LM, Hien DA, Fitzpatrick S, Killeen TK, Back SE, Lopez-Castro T. Measurement nonequivalence of the Clinician-Administered PTSD Scale by race/ethnicity: Implications for quantifying posttraumatic stress disorder severity. Psychol Assess. 2020 Nov;32(11):1015-1027. doi: 10.1037/pas0000943. Epub 2020 Aug 27.
citation: Morgan-Lopez AA, Killeen TK, Saavedra LM, Hien DA, Fitzpatrick S, Ruglass LM, Back SE. Crossover between diagnostic and empirical categorizations of full and subthreshold PTSD. J Affect Disord. 2020 Sep 1;274:832-840. doi: 10.1016/j.jad.2020.05.031. Epub 2020 May 24.
citation: Hameed M, O'Doherty L, Gilchrist G, Tirado-Munoz J, Taft A, Chondros P, Feder G, Tan M, Hegarty K. Psychological therapies for women who experience intimate partner violence. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013017. doi: 10.1002/14651858.CD013017.pub2.
citation: Morgan-Lopez AA, Saavedra LM, Hien DA, Killeen TK, Back SE, Ruglass LM, Fitzpatrick S, Lopez-Castro T, Patock-Peckham JA. Estimation of equable scale scores and treatment outcomes from patient- and clinician-reported PTSD measures using item response theory calibration. Psychol Assess. 2020 Apr;32(4):321-335. doi: 10.1037/pas0000789. Epub 2019 Dec 5.
citation: Resko SM, Brown S, Mendoza NS, Crosby S, Gonzalez-Prendes A. Perceived Treatment Needs Among Women With Co-occurring Substance Use Disorders and PTSD. J Dual Diagn. 2016 Jul-Dec;12(3-4):271-281. doi: 10.1080/15504263.2016.1248309. Epub 2016 Oct 14.
citation: Lopez-Castro T, Hu MC, Papini S, Ruglass LM, Hien DA. Pathways to change: Use trajectories following trauma-informed treatment of women with co-occurring post-traumatic stress disorder and substance use disorders. Drug Alcohol Rev. 2015 May;34(3):242-51. doi: 10.1111/dar.12230. Epub 2015 Mar 4.
citation: Morgan-Lopez AA, Saavedra LM, Hien DA, Campbell AN, Wu E, Ruglass L, Patock-Peckham JA, Bainter SC. Indirect effects of 12-session seeking safety on substance use outcomes: overall and attendance class-specific effects. Am J Addict. 2014 May-Jun;23(3):218-25. doi: 10.1111/j.1521-0391.2014.12100.x.
citation: Ruglass LM, Hien DA, Hu MC, Campbell AN. Associations between post-traumatic stress symptoms, stimulant use, and treatment outcomes: a secondary analysis of NIDA's Women and Trauma study. Am J Addict. 2014 Jan-Feb;23(1):90-5. doi: 10.1111/j.1521-0391.2013.12068.x. Epub 2013 Jun 26.
citation: Morgan-Lopez AA, Saavedra LM, Hien DA, Campbell AN, Wu E, Ruglass L. Synergy between seeking safety and twelve-step affiliation on substance use outcomes for women. J Subst Abuse Treat. 2013 Aug;45(2):179-89. doi: 10.1016/j.jsat.2013.01.015. Epub 2013 Apr 1.
citation: Hien DA, Morgan-Lopez AA, Campbell AN, Saavedra LM, Wu E, Cohen L, Ruglass L, Nunes EV. Attendance and substance use outcomes for the Seeking Safety program: sometimes less is more. J Consult Clin Psychol. 2012 Feb;80(1):29-42. doi: 10.1037/a0026361. Epub 2011 Dec 19.
citation: Hien DA, Jiang H, Campbell AN, Hu MC, Miele GM, Cohen LR, Brigham GS, Capstick C, Kulaga A, Robinson J, Suarez-Morales L, Nunes EV. Do treatment improvements in PTSD severity affect substance use outcomes? A secondary analysis from a randomized clinical trial in NIDA's Clinical Trials Network. Am J Psychiatry. 2010 Jan;167(1):95-101. doi: 10.1176/appi.ajp.2009.09091261. Epub 2009 Nov 16.
citation: Hien DA, Wells EA, Jiang H, Suarez-Morales L, Campbell AN, Cohen LR, Miele GM, Killeen T, Brigham GS, Zhang Y, Hansen C, Hodgkins C, Hatch-Maillette M, Brown C, Kulaga A, Kristman-Valente A, Chu M, Sage R, Robinson JA, Liu D, Nunes EV. Multisite randomized trial of behavioral interventions for women with co-occurring PTSD and substance use disorders. J Consult Clin Psychol. 2009 Aug;77(4):607-19. doi: 10.1037/a0016227.
citation: Hien DA, Campbell AN, Killeen T, Hu MC, Hansen C, Jiang H, Hatch-Maillette M, Miele GM, Cohen LR, Gan W, Resko SM, DiBono M, Wells EA, Nunes EV. The impact of trauma-focused group therapy upon HIV sexual risk behaviors in the NIDA Clinical Trials Network "Women and trauma" multi-site study. AIDS Behav. 2010 Apr;14(2):421-30. doi: 10.1007/s10461-009-9573-7. Epub 2009 May 19.