Overview

This trial is active, not recruiting.

Condition post-traumatic stress disorder
Treatments stair/nt treatment, treatment as usual (tau)
Phase phase 2/phase 3
Sponsor Palo Alto Veterans Institute for Research
Collaborator New York University
Start date January 2012
End date April 2016
Trial size 352 participants
Trial identifier NCT01488539, 1R01MH086611-01A2, CLO0001AGG

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patients will receive STAIR/NT treatment
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.
(Other)
Patients will receive Treatment as Usual (TAU)
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.

Primary Outcomes

Measure
Clinician-Administered PTSD Scale (CAPS)
time frame: Change from baseline to week 28 after randomization
Clinician-Administered PTSD Scale (CAPS)
time frame: Change from baseline to week 36 after randomization
Clinician-Administered PTSD Scale (CAPS)
time frame: Change from baseline to week 48 after randomization

Secondary Outcomes

Measure
The Inventory of Interpersonal Problems (IIP)
time frame: Change from baseline to week 28 after randomization
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
The Inventory of Interpersonal Problems (IIP)
time frame: Change from baseline to week 48 after randomization
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

Eligibility Criteria

Female participants from 18 years up to 65 years old.

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)

Additional Information

Official title Implementation of an Evidence Based PTSD Treatment in Public Sector Settings
Principal investigator Marylene Cloitre, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Palo Alto Veterans Institute for Research.