Clinical trial NCT01488539: Implementation of an Evidence Based Post-Traumatic Stress Disorder (PTSD) Treatment in Public Sector Settings
Official title: Implementation of an Evidence Based PTSD Treatment in Public Sector Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: Stress Disorders, Post-Traumatic
PTSD
Adult Survivors of Child Abuse
Women
Interpersonal violence
psychological trauma
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: New York University
name: Grady Health System
name: Nathan Kline Institute for Psychiatric Research
name: Georgetown University
name: Harvard Medical School (HMS and HSDM)
name: UConn Health
name: VA New York Harbor Healthcare System
name: National Institute of Mental Health (NIMH)
First posted: 2011-12-08
Enrollment: 210
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 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)

Primary outcomes:
measure: Clinician Assessed PTSD Symptom Severity
timeFrame: Baseline, 28, 36, 48 weeks
measure: PTSD Diagnosis
timeFrame: Baseline, 28, 36, 48 weeks
Secondary outcomes:
measure: Emotion Regulation Problems
timeFrame: Baseline, 12, 28, 36, 48 weeks
measure: Interpersonal problems
timeFrame: Baseline, 12, 28, 36, 48 weeks
measure: Psychosocial Functioning
timeFrame: Baseline, 28, 36, 48 weeks
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Washington
country: United States
facility: Georgetown University School of Medicine
state: District of Columbia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Cambridge
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
city: New York
country: United States
facility: New York University- Bellevue
state: New York
Study officials:
affiliation: VA Palo Alto Health Care System
name: Marylene Cloitre, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cloitre M, Henn-Haase C, Herman JL, Jackson C, Kaslow N, Klein C, Mendelsohn M, Petkova E. A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial. Trials. 2014 May 29;15:197. doi: 10.1186/1745-6215-15-197.