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

NCT01488539 | Completed DMC

• 2 other identifiers: CLO0001AGG1R01MH086611-01A2
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

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

Conditions

Post-Traumatic Stress Disorder

Keywords

Stress Disorders, Post-Traumatic; PTSD; Adult Survivors of Child Abuse; Women; Interpersonal violence; psychological trauma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Emotion Regulation Problems

  Baseline, 12, 28, 36, 48 weeks

• Interpersonal problems

  Baseline, 12, 28, 36, 48 weeks

• Psychosocial Functioning

  Baseline, 28, 36, 48 weeks

Study Arms (2)

STAIR/NT

EXPERIMENTAL

Patients will receive STAIR/NT treatment

Behavioral: STAIR/NT treatment

Treatment as Usual (TAU)

OTHER

Patients will receive Treatment as Usual (TAU)

Behavioral: Treatment as Usual (TAU)

Interventions

STAIR/NT treatment BEHAVIORAL

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.

STAIR/NT

Treatment as Usual (TAU) BEHAVIORAL

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.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (5)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Georgetown University School of Medicine

Washington D.C., District of Columbia, 20057, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Cambridge Health Alliance

Cambridge, Massachusetts, 02139, United States

Location

New York University- Bellevue

New York, New York, 10016, United States

Location

Related 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.

  PMID: 24886235 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Trauma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Marylene Cloitre, PhD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Science Specialist

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

US (5)