Enhancing Exposure Therapy for Post-traumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Texas at Austin
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Michael J. Telch, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01574118
First received: April 3, 2012
Last updated: January 21, 2014
Last verified: January 2014

April 3, 2012
January 21, 2014
April 2012
March 2015   (final data collection date for primary outcome measure)
Change from baseline in PTSD symptom severity [ Time Frame: Weeks 6, 10, 22 ] [ Designated as safety issue: No ]
PTSD Symptom Scale - Interview Version
Same as current
Complete list of historical versions of study NCT01574118 on ClinicalTrials.gov Archive Site
  • Change from baseline in depression symptom severity [ Time Frame: Weeks 6, 10, 22. ] [ Designated as safety issue: No ]
    Quick Inventory of Depressive Symptomatology - Self-Report
  • Change from baseline in trauma-related cognitions [ Time Frame: Weeks 6, 10, 22. ] [ Designated as safety issue: No ]
    Post-Traumatic Cognitions Inventory - Self-Report
  • Change from baseline in general physical and psychological health [ Time Frame: Weeks 6, 10, 22 ] [ Designated as safety issue: No ]
    Medical Outcomes Study Short Form 36, Version 2 - Self-report
  • Change from baseline in work, social/leisure activities, and family/home life functioning [ Time Frame: Weeks 6, 10, 22. ] [ Designated as safety issue: No ]
    Sheehan Disability Scale - Self-report
Same as current
Not Provided
Not Provided
 
Enhancing Exposure Therapy for Post-traumatic Stress Disorder
Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies

This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.

This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Posttraumatic Stress Disorder
  • Behavioral: Standard Prolonged Exposure Therapy
    Individuals will receive ten twice-weekly exposure therapy sessions (90-120 min each session) over a 5-week period.
    Other Name: Standard PE
  • Behavioral: Brief Enhanced Exposure Therapy
    This brief 7-session intervention incorporates two experimental augmentation strategies to imaginal exposure based on basic fear attenuation research in rodents. These include a pre-session fear memory retrieval procedure and a compound fear extinction procedure.
  • Experimental: Brief Enhanaced Exposure Therapy
    This treatment involves daily therapy sessions with a therapist for 50 to 60 minutes for a total of 7 sessions over a 10-day period.
    Intervention: Behavioral: Brief Enhanced Exposure Therapy
  • Active Comparator: Standard Prolonged Exposure Therapy
    Participants will receive a widely established consisting of ten twice-weekly psychotherapy sessions (90-120 min each session).
    Intervention: Behavioral: Standard Prolonged Exposure Therapy
  • Delayed Prolonged Exposure Therapy
    Individuals undergo three assessments (Week 0, 3, and 6) prior to receiving treatment. After the six weeks, individuals receive ten twice-weekly psychotherapy sessions (90-120 min each session).
    Intervention: Behavioral: Standard Prolonged Exposure Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
March 2016
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
  2. Between the age of 18 and 65.
  3. Medication status stable for at least 6 weeks

Exclusion Criteria:

  1. Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
  2. Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
  3. Current diagnosis of alcohol or substance dependence within the 3 previous months.
  4. Unwilling or unable to discontinue current trauma-focused psychotherapy.
  5. Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
  6. Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.
Both
18 Years to 65 Years
Yes
Contact: Michael J Telch, Ph.D. (512) 404-9118 Telch@austin.utexas.edu
Contact: Adam Cobb, M.S.W. (325) 201-4228 adamrcobb@yahoo.com
United States
 
NCT01574118
2012-02-0100
No
Michael J. Telch, University of Texas at Austin
University of Texas at Austin
University of Pennsylvania
Principal Investigator: Michael J Telch, Ph.D. University of Texas at Austin
University of Texas at Austin
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP