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.

Study Overview

• Status: Terminated
• Conditions: Chronic Posttraumatic Stress Disorder
• Intervention / Treatment: 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; Behavioral: Breathing retraining

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
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Brief Enhanaced Exposure Therapy; 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	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 Names: 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 Names: 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 Names: 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 Names: 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 Names: 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 Names: Deepened Extinction
ACTIVE_COMPARATOR: Standard Prolonged Exposure Therapy; 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	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 Names: 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 Names: 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: 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 Names: In vivo exposure outside of session; Behavioral: Breathing retraining; Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.; Other Names: Relaxed breathing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in PTSD symptom severity	PTSD Symptom Scale - Interview Version	Weeks 6, 10, 22

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in depression symptom severity	Quick Inventory of Depressive Symptomatology - Self-Report	Weeks 6, 10, 22.
Change from baseline in trauma-related cognitions	Post-Traumatic Cognitions Inventory - Self-Report	Weeks 6, 10, 22.
Change from baseline in general physical and psychological health	Medical Outcomes Study Short Form 36, Version 2 - Self-report	Weeks 6, 10, 22
Change from baseline in work, social/leisure activities, and family/home life functioning	Sheehan Disability Scale - Self-report	Weeks 6, 10, 22.

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): March 1, 2020

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 5, 2012
• First Posted (ESTIMATE): April 10, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 23, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: PTSD; Posttraumatic Stress Disorder; Psychotherapy; Prolonged Exposure; Exposure Therapy; Fear Memory Retrieval; Compound extinction; Deepened extinction
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2012-02-0100