Enhancing Exposure Therapy for Post-traumatic Stress Disorder

Chronic Posttraumatic Stress Disorder Clinical Trial

Official title:

Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01574118
• Other study ID #: 2012-02-0100
• Status: Terminated
• Phase: Phase 2
• Start date: April 2012
• Est. completion date: March 2020

Study information

• Verified date: August 2022
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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.
• 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.
• Psychoeducation
Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.
• 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.
• 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.
• Breathing retraining
Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.
• 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.
• Compound extinction
The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.

Locations

Country	Name	City	State
United States	Laboratory for the Study of Anxiety Disorders, University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

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