New York State Psychiatric Institute
New York, 10032, United States
NCT Number: NCT00739765
This study will examine whether interpersonal psychotherapy is as effective in treating post-traumatic stress disorder as the established therapies of prolonged exposure and relaxation.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
New York, 10032, United States
Post-traumatic stress disorder (PTSD) is caused by a traumatic experience often involving physical harm or the threat of harm or death. The emotional numbness and traumatic flashbacks symptomatic of PTSD interfere with everyday life for approximately 7.7 million adults. Besides prescription drug treatment, only exposure-based therapies, like prolonged exposure (PE) therapy, have been proved effective in treating PTSD. Interpersonal psychotherapy (IPT), which is not based on exposure, is effective in treating mood disorders, and pilot studies indicate it may also be effective in treating PTSD. IPT treats patients by helping them to improve their interpersonal functioning, as opposed to PE, which helps patients by guiding them to recreate traumatic memories in safe circumstances. This study will determine whether IPT is as effective as PE, the gold standard, in treating PTSD. Relaxation therapy, a commonly used control therapy for studies of PTSD, will be used for that purpose here.
All participants will be screened for PTSD, with those meeting the criteria being randomly assigned to one of the following three treatment groups:
All treatments will last 14 weeks, with assessments made by mental health professionals at screening, the midpoint of the study, the end of the study, and a 3-month follow-up. PTSD symptoms will be assessed through clinical interviews and self-report measures. In addition, participants will complete other interviews and tests that will examine a variety of factors relating to mental health, including comorbidity of other conditions, affect, social functioning, and quality of life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
Ten 90-minute sessions, distributed over 14 weeks, of prolonged exposure, which involves the repeated, detailed recounting of the trauma to develop a coherent narrative and repeated exposure to reminders of the trauma
Nine 90-minute sessions and one 30-minute session, distributed over 14 weeks, that focus on muscle relaxation to address the physical symptoms of PTSD
Time frame: After 14 weeks of treatment
Continuous measure scale of PTSD symptoms severity. Generally considered state of the art. Range 0-136 (17 items each rated for frequency and for intensity, each on a 0-4 scale). Scores >50 indicate at least moderately severe PTSD; scores <20 were defined as remission. See Blake DD, Weathers FW, Nagy LM, et al: The development of a clinician-administered PTSD scale. J Trauma Stress 1995; 8:75-90; Weathers FW, Keane TM, Davidson JRT: Clinician-Administered PTSD Scale: a review of the first ten years of research. Depression and Anxiety 2001;13:132-156
Time frame: After 14 weeks of treatment
Continuous scale to measure depressive symptom severity with a potential range from 0 to 74. Higher scores indicate more severe depressive symptoms. Scores <8 are generally considered not depressed; 8-12 mildly depressed; 13-19 moderately depressed; 20 and greater, severely depressed. Reference: Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;25:56-62
New York State Psychiatric Institute
Other
Psychotherapies for Chronic Post-Traumatic Stress Disorder
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