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Enhancing Exposure Therapy for Post-traumatic Stress Disorder

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01574118
Enrollment
27
Registered
2012-04-10
Start date
2012-04-30
Completion date
2020-03-31
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Posttraumatic Stress Disorder

Keywords

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

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.

Interventions

BEHAVIORALRevisiting 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.

BEHAVIORALProcessing 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.

BEHAVIORALPsychoeducation

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

BEHAVIORALTrauma 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.

BEHAVIORALExposure 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.

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

BEHAVIORALExposure 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.

BEHAVIORALCompound extinction

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

Sponsors

University of Pennsylvania
CollaboratorOTHER
University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in PTSD symptom severityWeeks 6, 10, 22PTSD Symptom Scale - Interview Version

Secondary

MeasureTime frameDescription
Change from baseline in depression symptom severityWeeks 6, 10, 22.Quick Inventory of Depressive Symptomatology - Self-Report
Change from baseline in trauma-related cognitionsWeeks 6, 10, 22.Post-Traumatic Cognitions Inventory - Self-Report
Change from baseline in general physical and psychological healthWeeks 6, 10, 22Medical Outcomes Study Short Form 36, Version 2 - Self-report
Change from baseline in work, social/leisure activities, and family/home life functioningWeeks 6, 10, 22.Sheehan Disability Scale - Self-report

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026