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

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.

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)