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
  Purpose

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.


Condition Intervention Phase
Chronic Posttraumatic Stress Disorder
Behavioral: Standard Prolonged Exposure Therapy
Behavioral: Brief Enhanced Exposure Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Change from baseline in PTSD symptom severity [ Time Frame: Weeks 6, 10, 22 ] [ Designated as safety issue: No ]
    PTSD Symptom Scale - Interview Version


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 54
Study Start Date: April 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Active Comparator: Standard Prolonged Exposure Therapy
Participants will receive a widely established consisting of ten twice-weekly psychotherapy sessions (90-120 min each session).
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
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).
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574118

Contacts
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

Locations
United States, Texas
Laboratory for the Stdy of Anxiety Disorders, University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
University of Pennsylvania
Investigators
Principal Investigator: Michael J Telch, Ph.D. University of Texas at Austin
  More Information

No publications provided

Responsible Party: Michael J. Telch, Principal Investigator, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01574118     History of Changes
Other Study ID Numbers: 2012-02-0100
Study First Received: April 3, 2012
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
PTSD
Posttraumatic Stress Disorder
Exposure Therapy
Prolonged Exposure
Fear Memory Retrieval
Compound extinction
Deepened extinction
Psychotherapy

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014