Enhancing Exposure Therapy for Post-traumatic Stress Disorder

NCT01574118 | Terminated Phase 2

• 1 other identifier: 2012-02-0100
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Posttraumatic Stress Disorder

Keywords

PTSD; Posttraumatic Stress Disorder; Exposure Therapy; Prolonged Exposure; Fear Memory Retrieval; Compound extinction; Deepened extinction; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in PTSD symptom severity

  PTSD Symptom Scale - Interview Version

  Weeks 6, 10, 22

Secondary Outcomes (4)

• Change from baseline in depression symptom severity

  Weeks 6, 10, 22.

• Change from baseline in trauma-related cognitions

  Weeks 6, 10, 22.

• Change from baseline in general physical and psychological health

  Weeks 6, 10, 22

• Change from baseline in work, social/leisure activities, and family/home life functioning

  Weeks 6, 10, 22.

Study Arms (3)

Brief Enhanaced Exposure Therapy

EXPERIMENTAL

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

Standard Prolonged Exposure Therapy

ACTIVE COMPARATOR

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

Delayed Treatment Control

NO INTERVENTION

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.

Interventions

Revisiting the Trauma memories BEHAVIORAL

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

Brief Enhanaced Exposure Therapy; Standard Prolonged Exposure Therapy

Processing the trauma memories BEHAVIORAL

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

Brief Enhanaced Exposure Therapy; Standard Prolonged Exposure Therapy

Psychoeducation BEHAVIORAL

Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.

Brief Enhanaced Exposure Therapy; Standard Prolonged Exposure Therapy

Trauma Memory Retrieval Trial BEHAVIORAL

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

Brief Enhanaced Exposure Therapy

Exposure to video clips related to the patient's trauma BEHAVIORAL

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

Brief Enhanaced Exposure Therapy

Breathing retraining BEHAVIORAL

Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.

Also known as: Relaxed breathing

Standard Prolonged Exposure Therapy

Exposure Homework BEHAVIORAL

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

Brief Enhanaced Exposure Therapy; Standard Prolonged Exposure Therapy

Compound extinction BEHAVIORAL

The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.

Also known as: Deepened Extinction

Brief Enhanaced Exposure Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas at Austin: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Michael J Telch, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2012
• First Posted: April 10, 2012
• Study Start: April 1, 2012
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

US (1)