Back to resultsEnhancing Exposure Therapy for Post-traumatic Stress Disorder
Primary Purpose
Chronic Posttraumatic Stress Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Revisiting the Trauma memories
Processing the trauma memories
Psychoeducation
Trauma Memory Retrieval Trial
Exposure to video clips related to the patient's trauma
Breathing retraining
Exposure Homework
Compound extinction
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Posttraumatic Stress Disorder focused on measuring PTSD, Posttraumatic Stress Disorder, Exposure Therapy, Prolonged Exposure, Fear Memory Retrieval, Compound extinction, Deepened extinction, Psychotherapy
Eligibility Criteria
Inclusion Criteria:
- Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
- Between the age of 18 and 65.
- Medication status stable for at least 6 weeks
Exclusion Criteria:
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
- 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).
- Current diagnosis of alcohol or substance dependence within the 3 previous months.
- Unwilling or unable to discontinue current trauma-focused psychotherapy.
- Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
- Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.
Sites / Locations
- Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Brief Enhanaced Exposure Therapy
Standard Prolonged Exposure Therapy
Delayed Treatment Control
Arm Description
The following interventions are included in this arm: Psycho-education addressing common reactions to trauma Revisiting the Trauma memories Processing the trauma memories In vivo Exposure homework *Use of a brief pre-exposure trauma memory retrieval trial Exposure to video clips related to the patient's trauma Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
The following interventions are included in this arm: Psycho-education addressing common reactions to trauma Revisiting of the Trauma memories Processing the trauma memories Breathing retraining In vivo Exposure homework
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.
Outcomes
Primary Outcome Measures
Change from baseline in PTSD symptom severity
PTSD Symptom Scale - Interview Version
Secondary Outcome Measures
Change from baseline in depression symptom severity
Quick Inventory of Depressive Symptomatology - Self-Report
Change from baseline in trauma-related cognitions
Post-Traumatic Cognitions Inventory - Self-Report
Change from baseline in general physical and psychological health
Medical Outcomes Study Short Form 36, Version 2 - Self-report
Change from baseline in work, social/leisure activities, and family/home life functioning
Sheehan Disability Scale - Self-report
Full Information
NCT ID
NCT01574118
First Posted
April 3, 2012
Last Updated
August 23, 2022
Sponsor
University of Texas at Austin
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01574118
Brief Title
Enhancing Exposure Therapy for Post-traumatic Stress Disorder
Official Title
Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
April 2012 (undefined)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Posttraumatic Stress Disorder
Keywords
PTSD, Posttraumatic Stress Disorder, Exposure Therapy, Prolonged Exposure, Fear Memory Retrieval, Compound extinction, Deepened extinction, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief Enhanaced Exposure Therapy
Arm Type
Experimental
Arm Description
The following interventions are included in this arm:
Psycho-education addressing common reactions to trauma
Revisiting the Trauma memories
Processing the trauma memories
In vivo Exposure homework
*Use of a brief pre-exposure trauma memory retrieval trial
Exposure to video clips related to the patient's trauma
Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script
Arm Title
Standard Prolonged Exposure Therapy
Arm Type
Active Comparator
Arm Description
The following interventions are included in this arm:
Psycho-education addressing common reactions to trauma
Revisiting of the Trauma memories
Processing the trauma memories
Breathing retraining
In vivo Exposure homework
Arm Title
Delayed Treatment Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Revisiting the Trauma memories
Other Intervention Name(s)
Trauma Revisiting
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Processing the trauma memories
Other Intervention Name(s)
Trauma Processing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Memory Retrieval Trial
Other Intervention Name(s)
Fear Retrieval
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exposure to video clips related to the patient's trauma
Other Intervention Name(s)
Exposure to trauma clips
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Breathing retraining
Other Intervention Name(s)
Relaxed breathing
Intervention Description
Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.
Intervention Type
Behavioral
Intervention Name(s)
Exposure Homework
Other Intervention Name(s)
In vivo exposure outside of session
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Compound extinction
Other Intervention Name(s)
Deepened Extinction
Intervention Description
The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.
Primary Outcome Measure Information:
Title
Change from baseline in PTSD symptom severity
Description
PTSD Symptom Scale - Interview Version
Time Frame
Weeks 6, 10, 22
Secondary Outcome Measure Information:
Title
Change from baseline in depression symptom severity
Description
Quick Inventory of Depressive Symptomatology - Self-Report
Time Frame
Weeks 6, 10, 22.
Title
Change from baseline in trauma-related cognitions
Description
Post-Traumatic Cognitions Inventory - Self-Report
Time Frame
Weeks 6, 10, 22.
Title
Change from baseline in general physical and psychological health
Description
Medical Outcomes Study Short Form 36, Version 2 - Self-report
Time Frame
Weeks 6, 10, 22
Title
Change from baseline in work, social/leisure activities, and family/home life functioning
Description
Sheehan Disability Scale - Self-report
Time Frame
Weeks 6, 10, 22.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
Between the age of 18 and 65.
Medication status stable for at least 6 weeks
Exclusion Criteria:
Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
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).
Current diagnosis of alcohol or substance dependence within the 3 previous months.
Unwilling or unable to discontinue current trauma-focused psychotherapy.
Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Telch, Ph.D.
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
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Enhancing Exposure Therapy for Post-traumatic Stress Disorder
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