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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Implementation of an Evidence Based PTSD Treatment in Public Sector Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488539
• Other study ID #: CLO0001AGG
• Secondary ID: 1R01MH086611-01A
• Status: Completed
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: April 1, 2017

Study information

• Verified date: August 2023
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia
United States	Cambridge Health Alliance	Cambridge	Massachusetts
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	New York University- Bellevue	New York	New York
United States	Georgetown University School of Medicine	Washington	District of Columbia

Sponsors (9)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Georgetown University, Grady Health System, Harvard Medical School (HMS and HSDM), Nathan Kline Institute for Psychiatric Research, National Institute of Mental Health (NIMH), New York University, UConn Health, VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Assessed PTSD Symptom Severity	Clinician Adminstered PTSD Scale for DSM-5 (CAPS-5) includes 20 items rated on a 5 point scale from 0 to 4. Possible total scores range from 0 to 80, with higher scores indicating more severe PTSD.	Baseline, 28, 36, 48 weeks
Primary	PTSD Diagnosis	Clinician Adminstered PTSD Scale for DSM-5 (CAPS-5) assess the presence of PTSD diagnosis following the requirements indicated by DSM-5. These include the presence of 5 symtpom clusters that include re-experiencing symptoms, avoidance symptoms, alterations in mood and cognitions and hyperarousal.	Baseline, 28, 36, 48 weeks
Secondary	Emotion Regulation Problems	The DERS is a 36 item self-report measure where items are scored from 0 to 4 indicating how frequently the problem occurs. Possible total scores can range from 0 to 144 with higher scores indicating more frequent problems.	Baseline, 12, 28, 36, 48 weeks
Secondary	Interpersonal problems	The Inventory of Interpersonal Problems-32 (IIP-32) is a 32 item measure where items are scored from 0 to 4. Possible total scores range from 0 to 128 with higher scores indicating more severe problems.	Baseline, 12, 28, 36, 48 weeks
Secondary	Psychosocial Functioning	SF-3 includes 3 items from the SF-36 which assess the impact of emotional problems on daily functioning	Baseline, 28, 36, 48 weeks