A Phase 2 interventional study of Revisiting the Trauma memories and Processing the trauma memories in Chronic Posttraumatic Stress Disorder, sponsored by University of Texas at Austin. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by University of Texas at Austin · Phase 2, Interventional, and 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.
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →University of Texas at Austin is the lead sponsor of 319 studies on the registry; 78 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · 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
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 · Behavioral: Processing the trauma memories · Behavioral: Psychoeducation · Behavioral: Breathing retraining · Behavioral: 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.
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.
Also known as: Trauma Revisiting
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.
Also known as: Trauma Processing
Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.
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.
Also known as: Fear Retrieval
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.
Also known as: Exposure to trauma clips
Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.
Also known as: Relaxed breathing
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.
Also known as: In vivo exposure outside of session
The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.
Also known as: Deepened Extinction
Change from baseline in PTSD symptom severity
PTSD Symptom Scale - Interview Version
Time frame: Weeks 6, 10, 22
Change from baseline in depression symptom severity
Quick Inventory of Depressive Symptomatology - Self-Report
Time frame: Weeks 6, 10, 22.
Change from baseline in trauma-related cognitions
Post-Traumatic Cognitions Inventory - Self-Report
Time frame: Weeks 6, 10, 22.
Change from baseline in general physical and psychological health
Medical Outcomes Study Short Form 36, Version 2 - Self-report
Time frame: Weeks 6, 10, 22
Change from baseline in work, social/leisure activities, and family/home life functioning
Sheehan Disability Scale - Self-report
Time frame: Weeks 6, 10, 22.
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University of Texas at Austin