Enhancing Exposure Therapy for Post-traumatic Stress Disorder

• ClinicalTrials.gov Identifier: NCT01574118
• Recruitment Status: Unknown
• First Posted: April 10, 2012
• Last Update Posted: January 26, 2015
• Sponsor: University of Texas at Austin
• Collaborator: University of Pennsylvania
• Information provided by (Responsible Party): Michael J. Telch, University of Texas at Austin

Tracking Information

• First Submitted Date: April 3, 2012
• First Posted Date: April 10, 2012
• Last Update Posted Date: January 26, 2015
• Study Start Date: April 2012
• Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 5, 2012)

Change from baseline in PTSD symptom severity [ Time Frame: Weeks 6, 10, 22 ]

PTSD Symptom Scale - Interview Version

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 5, 2012)

• Change from baseline in depression symptom severity [ Time Frame: Weeks 6, 10, 22. ]
  Quick Inventory of Depressive Symptomatology - Self-Report
• Change from baseline in trauma-related cognitions [ Time Frame: Weeks 6, 10, 22. ]
  Post-Traumatic Cognitions Inventory - Self-Report
• Change from baseline in general physical and psychological health [ Time Frame: Weeks 6, 10, 22 ]
  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. ]
  Sheehan Disability Scale - Self-report

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Enhancing Exposure Therapy for Post-traumatic Stress Disorder
• Official Title: Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Posttraumatic Stress Disorder

Intervention

• 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

Study Arms

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 5, 2012): 54
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2018
• Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01574118
• Other Study ID Numbers: 2012-02-0100
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michael J. Telch, University of Texas at Austin
• Study Sponsor: University of Texas at Austin
• Collaborators: University of Pennsylvania

Investigators

• Principal Investigator: Michael J Telch, Ph.D.; University of Texas at Austin

• PRS Account: University of Texas at Austin
• Verification Date: January 2015