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
  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: 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: Breathing retraining
Behavioral: Exposure Homework
Behavioral: Compound extinction
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 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: 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
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
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: 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
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.

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 Study of Anxiety Disorders, University of Texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Michael J Telch, Ph.D.    512-404-9118    Telch@austin.utexas.edu   
Contact: Adam L Cobb, M.A.    (512) 404-9118    adamrcobb@utexas.edu   
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 22, 2015
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:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 30, 2015