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

NCT01488539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2023-08-18

No results posted yet for this study

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

Conditions

  • Post-Traumatic Stress Disorder

Interventions

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • New York University

    collaborator OTHER
  • Grady Health System

    collaborator OTHER
  • Nathan Kline Institute for Psychiatric Research

    collaborator OTHER
  • Georgetown University

    collaborator OTHER
  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • UConn Health

    collaborator OTHER
  • VA New York Harbor Healthcare System

    collaborator FED
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Palo Alto Veterans Institute for Research

    lead OTHER

Principal Investigators

  • Marylene Cloitre, PhD · VA Palo Alto Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-01
Primary Completion
2016-04-01
Completion
2017-04-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01488539 on ClinicalTrials.gov