Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
---|---|---|
Post-Traumatic Stress Disorder |
Behavioral: Interpersonal Psychotherapy Behavioral: Prolonged Exposure Therapy Behavioral: Relaxation Therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Psychotherapies for Chronic Post-Traumatic Stress Disorder |
Estimated Enrollment: | 165 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1 IPT: Experimental
Participants will receive interpersonal psychotherapy.
|
Behavioral: Interpersonal Psychotherapy
14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
|
2 PE: Active Comparator
Participants will receive prolonged exposure therapy.
|
Behavioral: Prolonged Exposure Therapy
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
|
3 Relaxation: Active Comparator
Participants will receive relaxation therapy.
|
Behavioral: Relaxation Therapy
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
|
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Helena Rosenfeld | 212-543-6747 | Helena@nyspi.cpmc.columbia.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: Helena Rosenfeld 212-543-6747 Helena@nyspi.cpmc.columbia.edu | |
Contact: John C. Markowitz, MD 212-543-6283 jcm42@columbia.edu | |
Principal Investigator: John C. Markowitz, MD |
Principal Investigator: | John C. Markowitz, MD | New York State Psychiatric Institution |
Responsible Party: | Research Foundation for Mental Health/New York State Psychiatric Institute ( John C. Markowitz, MD, Research Psychiatrist ) |
Study ID Numbers: | R01 MH079078, DATR AD-TS |
Study First Received: | August 20, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00739765 |
Health Authority: | United States: Federal Government |
Trauma Psychotherapy Anxiety |
Anxiety Disorders Mental Disorders Wounds and Injuries |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Pathologic Processes Disease |