Implementation of an Evidence Based Post-Traumatic Stress Disorder (PTSD) Treatment in Public Sector Settings

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Palo Alto Institute for Research and Education, Inc
Sponsor:
Collaborators:
New York University
London Health Sciences Centre
Cambridge Health Alliance
Grady Health System
Nathan Kline Institute for Psychiatric Research
Christie's Place
Information provided by (Responsible Party):
Marylène Cloitre, Palo Alto Institute for Research and Education, Inc
ClinicalTrials.gov Identifier:
NCT01488539
First received: December 2, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

Researchers hope to learn whether a flexibly applied cognitive behavioral treatment for Post-Traumatic Stress Disorder (PTSD) is more effective than the psychotherapy usually provided in the clinic (called Treatment as Usual or TAU). Primary Hypothesis: STAIR/NT will be superior to TAU in improving PTSD symptoms at 28, 36 and 48 weeks post-randomization


Condition Intervention Phase
Post-Traumatic Stress Disorder
Behavioral: STAIR/NT treatment
Behavioral: Treatment as Usual (TAU)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implementation of an Evidence Based PTSD Treatment in Public Sector Settings

Resource links provided by NLM:


Further study details as provided by Palo Alto Institute for Research and Education, Inc:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 28 after randomization ] [ Designated as safety issue: No ]
    (Blake et al., 1995; Weathers, Keane, & Davidson, 2001)

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 36 after randomization ] [ Designated as safety issue: No ]
    (Blake et al., 1995; Weathers, Keane, & Davidson, 2001)

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 48 after randomization ] [ Designated as safety issue: No ]
    (Blake et al., 1995; Weathers, Keane, & Davidson, 2001)


Secondary Outcome Measures:
  • The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 28 after randomization ] [ Designated as safety issue: No ]
    (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 ] [ Designated as safety issue: No ]
  • The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 36 after randomization ] [ Designated as safety issue: No ]
    (Horowitz, Rosenberg, Baer, Ureno, & Villasenor, 1988)

  • The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 48 after randomization ] [ Designated as safety issue: No ]
    (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 ] [ Designated as safety issue: No ]
  • Global Assessment of Functioning (GAF) Scale (DSM - IV Axis V) [ Time Frame: Change from baseline to week 48 after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: January 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STAIR/NT
Patients will receive STAIR/NT treatment
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)
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488539

Contacts
Contact: Donn Garvert, MS 650-493-5000 ext 27950 donn.garvert@va.gov
Contact: Marylene Cloitre, PhD 650-493-5000 ext 28353 marylene.cloitre@va.gov

Locations
United States, California
VA Palo Alto Health Care System, NC-PTSD, Dissemination and Training Division Active, not recruiting
Palo Alto, California, United States, 94304
Christie's Place Recruiting
San Diego, California, United States, 92101
Contact: Erin Falvey, PhD    619-702-4186 ext 307    falvey@christiesplace.org   
Principal Investigator: Erin Falvey, PhD         
United States, Georgia
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Contact: Nadine Kaslow, PhD    404-616-4757    nkaslow@emory.edu   
Principal Investigator: Nadine Kaslow, PhD         
United States, Massachusetts
Cambridge Health Alliance Recruiting
Cambridge, Massachusetts, United States, 02139
Contact: Judith L Herman, MD    617-503-2307    herman.j@comcast.net   
Contact: Michaela Mendelsohn, PhD    617-503-2307    michaela.mendelsohn@gmail.com   
Principal Investigator: Judith L Herman, MD         
Principal Investigator: Michaela Mendelsohn, PhD         
United States, New York
New York University- Bellevue Recruiting
New York, New York, United States, 10016
Contact: Clare Henn-Haase, PsyD    646-737-4920    Clare.Henn-Haase@nyumc.org   
Principal Investigator: Clare Henn-Haase, PsyD         
Sub-Investigator: Eva Petkova, PhD         
The Nathan S. Kline Institute for Psychiatric Research (NKI) Active, not recruiting
Orangeburg, New York, United States, 10962
Canada, Ontario
London Health Sciences Centre Active, not recruiting
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Palo Alto Institute for Research and Education, Inc
New York University
London Health Sciences Centre
Cambridge Health Alliance
Grady Health System
Nathan Kline Institute for Psychiatric Research
Christie's Place
Investigators
Principal Investigator: Marylene Cloitre, PhD VA Palo Alto Health Care System
  More Information

Publications:
Additional 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 Institute for Research and Education, Inc
ClinicalTrials.gov Identifier: NCT01488539     History of Changes
Other Study ID Numbers: CLO0001AGG, 1R01MH086611-01A2
Study First Received: December 2, 2011
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Palo Alto Institute for Research and Education, Inc:
Stress Disorders, Post-Traumatic
PTSD
Adult Survivors of Child Abuse
Women
Interpersonal violence
psychological trauma

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014