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Enhancing Exposure Therapy for Post-traumatic Stress Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 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 22, 2015
Last verified: January 2015

April 3, 2012
January 22, 2015
April 2012
March 2017   (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: Revisiting the Trauma memories
    Patient engages in repeated revisiting of their trauma memory under the guidance of the therapist for about 40 minutes. During each revisiting trial the patient closes their eyes and verbally describes the trauma and the feeling and thoughts experienced during the trauma.
    Other Name: Trauma Revisiting
  • Behavioral: Processing the trauma memories
    The patient and therapist discuss the patient's experience during the trauma revisiting with the goal of helping the patient gain alternative perspectives of the trauma.
    Other Name: Trauma Processing
  • Behavioral: Psychoeducation
    Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.
  • Behavioral: Trauma Memory Retrieval Trial
    Prior to the start of Imaginal Exposure, the patient is asked to recall a threatening element of their trauma memory for 1 minute. This is followed by a 30-minute rest-period prior to beginning imaginal exposure.
    Other Name: Fear Retrieval
  • Behavioral: Exposure to video clips related to the patient's trauma
    Patient is seated in front of a computer monitor and instructed to view a 30-min looped video clip that thematically resembles the patient's trauma.
    Other Name: Exposure to trauma clips
  • Behavioral: Breathing retraining
    Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.
    Other Name: Relaxed breathing
  • Behavioral: Exposure Homework
    Therapist assists the patient in identifying trauma-related situations/activities that the patient is avoiding and encourages the patient to begin to confront these situations between sessions.
    Other Name: In vivo exposure outside of session
  • Behavioral: Compound extinction
    The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.
    Other Name: Deepened Extinction
  • Experimental: Brief Enhanaced Exposure Therapy

    The following interventions are included in this arm:

    1. Psycho-education addressing common reactions to trauma
    2. Revisiting the Trauma memories
    3. Processing the trauma memories
    4. In vivo Exposure homework
    5. *Use of a brief pre-exposure trauma memory retrieval trial
    6. Exposure to video clips related to the patient's trauma
    7. Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
    Interventions:
    • Behavioral: Revisiting the Trauma memories
    • Behavioral: Processing the trauma memories
    • Behavioral: Psychoeducation
    • Behavioral: Trauma Memory Retrieval Trial
    • Behavioral: Exposure to video clips related to the patient's trauma
    • Behavioral: Exposure Homework
    • Behavioral: Compound extinction
  • Active Comparator: Standard Prolonged Exposure Therapy

    The following interventions are included in this arm:

    1. Psycho-education addressing common reactions to trauma
    2. Revisiting of the Trauma memories
    3. Processing the trauma memories
    4. Breathing retraining
    5. In vivo Exposure homework
    Interventions:
    • Behavioral: Revisiting the Trauma memories
    • Behavioral: Processing the trauma memories
    • Behavioral: Psychoeducation
    • Behavioral: Breathing retraining
    • Behavioral: Exposure Homework
  • No Intervention: Delayed Treatment Control
    Patients assigned to this arm receive assessment only (Week 0, 3, and 6) prior to receiving standard prolonged exposure therapy using the Foa et al treatment manual.
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 2018
March 2017   (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   (Adult)
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
Not Provided
Not Provided
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 2015

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