Enhancing Exposure Therapy for Post-traumatic Stress Disorder

Phase 2

Terminated

• Conditions: Chronic Posttraumatic Stress Disorder

• Registration Number: NCT01574118
• Lead Sponsor: University of Texas at Austin

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-03
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-10
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline in PTSD symptom severity	Weeks 6, 10, 22	PTSD Symptom Scale - Interview Version

Secondary Outcome Measures

Name	Time	Method
Change from baseline in trauma-related cognitions	Weeks 6, 10, 22.	Post-Traumatic Cognitions Inventory - Self-Report
Change from baseline in work, social/leisure activities, and family/home life functioning	Weeks 6, 10, 22.	Sheehan Disability Scale - Self-report
Change from baseline in general physical and psychological health	Weeks 6, 10, 22	Medical Outcomes Study Short Form 36, Version 2 - Self-report
Change from baseline in depression symptom severity	Weeks 6, 10, 22.	Quick Inventory of Depressive Symptomatology - Self-Report

Trial Locations

Locations (1)

Laboratory for the Study of Anxiety Disorders, University of Texas at Austin; 🇺🇸 Austin, Texas, United States