Implementation of an Evidence Based Post-Traumatic Stress Disorder (PTSD) Treatment in Public Sector Settings
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ClinicalTrials.gov Identifier: NCT01488539 |
Recruitment Status : Unknown
Verified May 2016 by Marylène Cloitre, Palo Alto Veterans Institute for Research.
Recruitment status was: Active, not recruiting
First Posted : December 8, 2011
Last Update Posted : May 30, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post-Traumatic Stress Disorder | Behavioral: STAIR/NT treatment Behavioral: Treatment as Usual (TAU) | Phase 2 Phase 3 |
PTSD among women is a particularly pernicious and chronic disorder associated with significant psychiatric comorbidity, high rates of suicidality, substance abuse, self-injury and multiple traumatization including repeated sexual assault and domestic violence. Public-sector mental health services are the disproportionate recipient of traumatized women with between 62% to 98% of treatment seeking women reporting a history of trauma and of those, up to 40% carry a diagnosis of PTSD with various comorbidities. Over 40 single-site randomized trials of cognitive-behavioral therapy for PTSD have been conducted. However, to date, there are only two large-sample randomized clinical trials which have evaluated the effectiveness of such treatments in the community and both of them concerned military populations. This application proposes to evaluate the effectiveness of an evidence-based PTSD treatment in the context of a collaborative partnership of four public mental health clinics serving diverse populations. The intervention is a two module, sequential treatment (STAIR/NT) in which the first module emphasizes present-focused skills training in affective and interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). This cognitive behavioral treatment was specifically designed to treat high risk, multiply traumatized women with chronic PTSD and has been demonstrated to provide significant and clinically substantial relief from PTSD as well as improvement in emotion management and interpersonal functioning.
The investigators will assess the effectiveness of STAIR/NT compared to Treatment as Usual (TAU) in the context of every day clinical care. The study is a randomized, controlled repeated measures intent-to-treat design to assess STAIR/NT as compared to TAU at post-treatment and three and six-month follow-up. Four sites (Western Ontario, Boston, New York and Atlanta), each situated within a large public sector mental health network, will enroll 88 treatment-seeking women with PTSD related to interpersonal violence yielding a total of 352 study participants. The primary outcome will be PTSD symptom severity. Secondary outcomes will be negative mood regulation self-efficacy, interpersonal problems and general level of psychiatric impairment (GAF scores). Exploratory aims include the examination of the relationship between variations in treatment implementation and treatment outcome as well as the influence of patient characteristics and other contextual (therapist and organization) variables likely to impact implementation. The investigators will also introduce web-based technology as a resource intended to strengthen clinical networks and maintain use of study materials after the trial has ended.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 352 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Implementation of an Evidence Based PTSD Treatment in Public Sector Settings |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | April 2016 |
Estimated Study Completion Date : | April 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: STAIR/NT
Patients will receive STAIR/NT treatment
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Behavioral: STAIR/NT treatment
STAIR/NT is a two module, sequential treatment in which the first module emphasizes present-focused skills training in affective an interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). STAIR/NT is a cognitive behavioral treatment that can be flexibly applied allowing treatment tailored to the needs of the individual patient; may be as brief as 16 sessions and as long as 24. |
Treatment as Usual (TAU)
Patients will receive Treatment as Usual (TAU)
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Behavioral: Treatment as Usual (TAU)
The Treatment as Usual intervention content varies from site to site and involve some combination of psychotherapy and pharmacotherapy. Treatment duration varies across sites and ranges from 30 to 45 sessions. |
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 28 after randomization ](Blake et al., 1995; Weathers, Keane, & Davidson, 2001)
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 36 after randomization ](Blake et al., 1995; Weathers, Keane, & Davidson, 2001)
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 48 after randomization ](Blake et al., 1995; Weathers, Keane, & Davidson, 2001)
- The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 28 after randomization ](Horowitz, Rosenberg, Baer, Ureno, & Villasenor, 1988)
- Global Assessment of Functioning (GAF) Scale (DSM - IV Axis V) [ Time Frame: Change from baseline to week 28 after randomization ]
- The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 36 after randomization ](Horowitz, Rosenberg, Baer, Ureno, & Villasenor, 1988)
- The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 48 after randomization ](Horowitz, Rosenberg, Baer, Ureno, & Villasenor, 1988)
- Global Assessment of Functioning (GAF) Scale (DSM - IV Axis V) [ Time Frame: Change from baseline to week 36 after randomization ]
- Global Assessment of Functioning (GAF) Scale (DSM - IV Axis V) [ Time Frame: Change from baseline to week 48 after randomization ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- A primary diagnosis of PTSD according to DSM-IV criteria with a CAPS score no lower than 40 (cf Weathers, Keane, & Davidson, 2001)
- PTSD symptoms that are a result of interpersonal violence
- at least one clear trauma memory
- Current age between 18 and 65
- If obtaining other (medication or psychosocial) treatment, must have completed at least a 3 month course of the treatment
Exclusion Criteria:
- Substance dependence and severe substance abuse disorders, current psychotic symptoms, unmedicated mania or bipolar disorder
- prominent current suicidal or homicidal ideation (a plan or intent versus a wish) or a suicide attempt within the past three months
- self-injurious behaviors in the last three months requiring medical attention
- Cognitive impairment indicated by chart diagnoses or observable cognitive difficulties
- Current involvement in a violent relationship defined as more than casual contact (e.g. dating or living with an abusive partner)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488539
United States, California | |
VA Palo Alto Health Care System, NC-PTSD, Dissemination and Training Division | |
Palo Alto, California, United States, 94304 | |
Christie's Place | |
San Diego, California, United States, 92101 | |
United States, Connecticut | |
University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06030 | |
United States, Georgia | |
Grady Health System | |
Atlanta, Georgia, United States, 30303 | |
United States, Massachusetts | |
Cambridge Health Alliance | |
Cambridge, Massachusetts, United States, 02139 | |
United States, New York | |
New York University- Bellevue | |
New York, New York, United States, 10016 | |
The Nathan S. Kline Institute for Psychiatric Research (NKI) | |
Orangeburg, New York, United States, 10962 | |
Canada, Ontario | |
London Health Sciences Centre | |
London, Ontario, Canada, N6A 5W9 |
Principal Investigator: | Marylene Cloitre, PhD | VA Palo Alto Health Care System |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marylène Cloitre, Associate Director of Research at the National Center for PTSD, Palo Alto Veterans Institute for Research |
ClinicalTrials.gov Identifier: | NCT01488539 |
Other Study ID Numbers: |
CLO0001AGG 1R01MH086611-01A2 ( U.S. NIH Grant/Contract ) |
First Posted: | December 8, 2011 Key Record Dates |
Last Update Posted: | May 30, 2016 |
Last Verified: | May 2016 |
Stress Disorders, Post-Traumatic PTSD Adult Survivors of Child Abuse |
Women Interpersonal violence psychological trauma |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |