Enhancing Exposure Therapy for Post-traumatic Stress Disorder

August 23, 2022 updated by: Michael J. Telch, University of Texas at Austin

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Brief Enhanaced Exposure Therapy

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
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:

  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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in PTSD symptom severity
Time Frame: Weeks 6, 10, 22
PTSD Symptom Scale - Interview Version
Weeks 6, 10, 22

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in depression symptom severity
Time Frame: Weeks 6, 10, 22.
Quick Inventory of Depressive Symptomatology - Self-Report
Weeks 6, 10, 22.
Change from baseline in trauma-related cognitions
Time Frame: Weeks 6, 10, 22.
Post-Traumatic Cognitions Inventory - Self-Report
Weeks 6, 10, 22.
Change from baseline in general physical and psychological health
Time Frame: Weeks 6, 10, 22
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
Time Frame: Weeks 6, 10, 22.
Sheehan Disability Scale - Self-report
Weeks 6, 10, 22.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas at Austin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-02-0100

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