Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Change from baseline in PTSD symptom severity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •Medication status stable for at least 6 weeks
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change from baseline in PTSD symptom severity
Time Frame: Weeks 6, 10, 22
PTSD Symptom Scale - Interview Version
Secondary Outcomes
- Change from baseline in trauma-related cognitions(Weeks 6, 10, 22.)
- Change from baseline in work, social/leisure activities, and family/home life functioning(Weeks 6, 10, 22.)
- Change from baseline in general physical and psychological health(Weeks 6, 10, 22)
- Change from baseline in depression symptom severity(Weeks 6, 10, 22.)
Investigators
Michael J. Telch
Principal Investigator
University of Texas at Austin