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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Implementation of an Evidence Based PTSD Treatment in Public Sector Settings

Brief Summary: 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

Detailed Summary:

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
Sponsor: Palo Alto Veterans Institute for Research

Current Primary Outcome:

  • 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)


Original Primary Outcome:

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Change from baseline to week 24 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)


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Negative Mood Regulation Scale (NMR) [ Time Frame: Change from baseline to week 24 after randomization ]
    (Cantanzaro & Mearns, 1990)
  • The Inventory of Interpersonal Problems (IIP) [ Time Frame: Change from baseline to week 24 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 24 after randomization ]
  • Negative Mood Regulation Scale (NMR) [ Time Frame: Change from baseline to week 36 after randomization ]
    (Cantanzaro & Mearns, 1990)
  • Negative Mood Regulation Scale (NMR) [ Time Frame: Change from baseline to week 48 after randomization ]
    (Cantanzaro & Mearns, 1990)
  • 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 ]


Information By: Palo Alto Veterans Institute for Research

Dates:
Date Received: December 2, 2011
Date Started: January 2012
Date Completion: April 2017
Last Updated: May 26, 2016
Last Verified: May 2016