Clinical trial NCT01574118: Enhancing Exposure Therapy for Post-traumatic Stress Disorder
Official title: Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Posttraumatic Stress Disorder
Keywords: PTSD
Posttraumatic Stress Disorder
Exposure Therapy
Prolonged Exposure
Fear Memory Retrieval
Compound extinction
Deepened extinction
Psychotherapy
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2012-04-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in PTSD symptom severity
timeFrame: Weeks 6, 10, 22
Secondary outcomes:
measure: Change from baseline in depression symptom severity
timeFrame: Weeks 6, 10, 22.
measure: Change from baseline in trauma-related cognitions
timeFrame: Weeks 6, 10, 22.
measure: Change from baseline in general physical and psychological health
timeFrame: Weeks 6, 10, 22
measure: Change from baseline in work, social/leisure activities, and family/home life functioning
timeFrame: Weeks 6, 10, 22.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Michael J Telch, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: