Back to resultsWomen's Treatment for Trauma and Substance Use Disorders - 1
Primary Purpose
Substance-Related Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Substance-Related Disorders focused on measuring behavioral intervention
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).
Sites / Locations
- Gateway Community Services
- The Villiage
- Addiction Research & Treatment Corp.-MSUCAS
- Addiction Research & Treatment Corp.-RISE
- Maryhaven, Inc.
- Charleston Center
- Residence XII
Outcomes
Primary Outcome Measures
Drug abstinence
Secondary Outcome Measures
Full Information
NCT ID
NCT00078156
First Posted
February 19, 2004
Last Updated
January 11, 2017
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00078156
Brief Title
Women's Treatment for Trauma and Substance Use Disorders - 1
Official Title
Women's Treatment for Trauma and Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
behavioral intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
409 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Primary Outcome Measure Information:
Title
Drug abstinence
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Hien, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gateway Community Services
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
The Villiage
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Addiction Research & Treatment Corp.-MSUCAS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11238
Country
United States
Facility Name
Addiction Research & Treatment Corp.-RISE
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11238
Country
United States
Facility Name
Maryhaven, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Charleston Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Residence XII
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34138594
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.
Results Reference
derived
PubMed Identifier
33175470
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.
Results Reference
derived
PubMed Identifier
32853005
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.
Results Reference
derived
PubMed Identifier
32664022
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.
Results Reference
derived
PubMed Identifier
32608505
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.
Results Reference
derived
PubMed Identifier
31804102
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.
Results Reference
derived
PubMed Identifier
27739935
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.
Results Reference
derived
PubMed Identifier
25735200
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.
Results Reference
derived
PubMed Identifier
24724878
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.
Results Reference
derived
PubMed Identifier
24313246
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.
Results Reference
derived
PubMed Identifier
23558158
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.
Results Reference
derived
PubMed Identifier
22182262
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.
Results Reference
derived
PubMed Identifier
19917596
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.
Results Reference
derived
PubMed Identifier
19634955
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.
Results Reference
derived
PubMed Identifier
19452271
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.
Results Reference
derived
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Women's Treatment for Trauma and Substance Use Disorders - 1
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