Implementation of an Evidence Based Post-Traumatic Stress Disorder (PTSD) Treatment in Public Sector Settings
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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 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.
    

Intervention name(s): STAIR/NT treatment; Treatment as Usual (TAU)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress Disorders, Post-Traumatic; PTSD; Adult Survivors of Child Abuse; Women; Interpersonal violence; psychological trauma