Enhancing Exposure Therapy for Post-traumatic Stress Disorder

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Chronic Posttraumatic Stress Disorder

Treatments: Behavioral: Revisiting the Trauma memories; Behavioral: Breathing retraining; Behavioral: Exposure Homework; Behavioral: Psychoeducation; Behavioral: Exposure to video clips related to the patient's trauma; Behavioral: Trauma Memory Retrieval Trial; Behavioral: Processing the trauma memories; Behavioral: Compound extinction

Study type: Interventional

Funder types: Other

Identifiers

NCT01574118

2012-02-0100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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27 participants in 3 patient groups

Brief Enhanaced Exposure Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Compound extinction

Behavioral: Processing the trauma memories

Behavioral: Trauma Memory Retrieval Trial

Behavioral: Exposure to video clips related to the patient's trauma

Behavioral: Psychoeducation

Behavioral: Exposure Homework

Behavioral: Revisiting the Trauma memories

Standard Prolonged Exposure Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Processing the trauma memories

Behavioral: Psychoeducation

Behavioral: Exposure Homework

Behavioral: Breathing retraining

Behavioral: Revisiting the Trauma memories

Delayed Treatment Control

No Intervention group

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.