Enhancing Exposure Therapy for Post-traumatic Stress Disorder

NCT ID: NCT01574118

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2020-03-31

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.

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.

Conditions

Chronic Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Revisiting the Trauma memories

Intervention Type: 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.

Processing the trauma memories

Intervention Type: 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.

Psychoeducation

Intervention Type: BEHAVIORAL

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

Intervention Type: 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.

Exposure to video clips related to the patient's trauma

Intervention Type: 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.

Exposure Homework

Intervention Type: 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.

Compound extinction

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Revisiting the Trauma memories

Intervention Type: 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.

Processing the trauma memories

Intervention Type: 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.

Psychoeducation

Intervention Type: BEHAVIORAL

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

Breathing retraining

Intervention Type: BEHAVIORAL

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

Exposure Homework

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Psychoeducation

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Breathing retraining

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Compound extinction

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Trauma Revisiting; Trauma Processing; Fear Retrieval; Exposure to trauma clips; Relaxed breathing; In vivo exposure outside of session; Deepened Extinction

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Michael J. Telch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Telch, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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

Austin, Texas, United States

Countries

United States

Other Identifiers

2012-02-0100

Identifier Type: -

Identifier Source: org_study_id