- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00739765
Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
Psychotherapies for Chronic Post-Traumatic Stress Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- Group 1 participants will receive IPT. They will meet weekly for fourteen 50-minute sessions focusing on interpersonal consequences of the trauma affecting them and their relationships with others.
- Group 2 participants will receive PE. They will meet for 10, unevenly spaced 90-minute sessions during which they will face the trauma responsible for their symptoms.
- Group 3 participants will receive relaxation therapy. They will meet for nine 90-minute sessions and one 30-minute session during which they will learn relaxation methods.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for primary, chronic PTSD
- At least moderately severe symptoms, defined by a minimum total (frequency plus severity) Clinician-Administered PTSD Scale score greater than 50
- Willing to undergo an independent clinical assessment and other ratings
Exclusion Criteria:
- Diagnosis of schizophrenia, bipolar disorder, or other psychotic disorders
- Psychiatric disorder due to a general medical condition
- Current substance abuse or dependence
- Acute suicide or homicide risk
- Unstable or life-threatening medical condition
- Primary diagnosis of borderline personality disorder, major depressive disorder, or major depression, melancholic subtype
- Diagnosis of antisocial personality disorder
- At least partial benefit from current treatment regimen
- Unwillingness to discontinue current ineffective psycho- or pharmacotherapy
- Inability to speak or read English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Interpersonal Psychotherapy (IPT)
Participants will receive interpersonal psychotherapy.
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14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
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Active Comparator: 2 Prolonged Exposure (PE)
Participants will receive prolonged exposure therapy.
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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
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Active Comparator: 3 Relaxation therapy
Participants will receive relaxation therapy.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered PTSD Scale (CAPS)
Time Frame: After 14 weeks of treatment
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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
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After 14 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Depression Rating Scale
Time Frame: After 14 weeks of treatment
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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
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After 14 weeks of treatment
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: John C. Markowitz, MD, New York State Psychiatric Institution
Publications and helpful links
General Publications
- Bleiberg KL, Markowitz JC. A pilot study of interpersonal psychotherapy for posttraumatic stress disorder. Am J Psychiatry. 2005 Jan;162(1):181-3. doi: 10.1176/appi.ajp.162.1.181.
- Markowitz JC, Bleiberg KL, Christos P, Levitan E. Solving interpersonal problems correlates with symptom improvement in interpersonal psychotherapy: preliminary findings. J Nerv Ment Dis. 2006 Jan;194(1):15-20. doi: 10.1097/01.nmd.0000195314.80210.41.
- Taylor S, Thordarson DS, Maxfield L, Fedoroff IC, Lovell K, Ogrodniczuk J. Comparative efficacy, speed, and adverse effects of three PTSD treatments: exposure therapy, EMDR, and relaxation training. J Consult Clin Psychol. 2003 Apr;71(2):330-8. doi: 10.1037/0022-006x.71.2.330.
- Markowitz JC, Milrod B, Bleiberg K, Marshall RD. Interpersonal factors in understanding and treating posttraumatic stress disorder. J Psychiatr Pract. 2009 Mar;15(2):133-40. doi: 10.1097/01.pra.0000348366.34419.28.
- Markowitz JC, Kaplowitz M, Suh EJ, Meehan KB, Neria Y, Jonker H, Rafaeli A, Lovell K. Treating patients who strain the research psychotherapy paradigm. J Nerv Ment Dis. 2012 Jul;200(7):594-7. doi: 10.1097/NMD.0b013e31825bfaf4.
- Amsel LV, Hunter N, Kim S, Fodor KE, Markowitz JC. Does a study focused on trauma encourage patients with psychotic symptoms to seek treatment? Psychiatr Serv. 2012 Apr;63(4):386-9. doi: 10.1176/appi.ps.201100251.
- Rafaeli AK, Markowitz JC. Interpersonal psychotherapy (IPT) for PTSD: a case study. Am J Psychother. 2011;65(3):205-23. doi: 10.1176/appi.psychotherapy.2011.65.3.205.
- Markowitz JC, Milrod BL. The importance of responding to negative affect in psychotherapies. Am J Psychiatry. 2011 Feb;168(2):124-8. doi: 10.1176/appi.ajp.2010.10040636. No abstract available.
- Markowitz JC. IPT and PTSD. Depress Anxiety. 2010 Oct;27(10):879-81. doi: 10.1002/da.20752. No abstract available.
- Markowitz JC, Lipsitz J, Milrod BL. Critical review of outcome research on interpersonal psychotherapy for anxiety disorders. Depress Anxiety. 2014 Apr;31(4):316-25. doi: 10.1002/da.22238. Epub 2014 Feb 3.
- Markowitz JC, Petkova E, Neria Y, Van Meter PE, Zhao Y, Hembree E, Lovell K, Biyanova T, Marshall RD. Is Exposure Necessary? A Randomized Clinical Trial of Interpersonal Psychotherapy for PTSD. Am J Psychiatry. 2015 May;172(5):430-40. doi: 10.1176/appi.ajp.2014.14070908. Epub 2015 Feb 13.
- Markowitz JC, Meehan KB, Petkova E, Zhao Y, Van Meter PE, Neria Y, Pessin H, Nazia Y. Treatment preferences of psychotherapy patients with chronic PTSD. J Clin Psychiatry. 2016 Mar;77(3):363-70. doi: 10.4088/JCP.14m09640.
- Markowitz JC, Petkova E, Biyanova T, Ding K, Suh EJ, Neria Y. EXPLORING PERSONALITY DIAGNOSIS STABILITY FOLLOWING ACUTE PSYCHOTHERAPY FOR CHRONIC POSTTRAUMATIC STRESS DISORDER. Depress Anxiety. 2015 Dec;32(12):919-26. doi: 10.1002/da.22436. Epub 2015 Oct 6.
- Markowitz JC, Neria Y, Lovell K, Van Meter PE, Petkova E. History of sexual trauma moderates psychotherapy outcome for posttraumatic stress disorder. Depress Anxiety. 2017 Aug;34(8):692-700. doi: 10.1002/da.22619. Epub 2017 Apr 4.
- Markowitz JC, Choo TH, Neria Y. Do Acute Benefits of Interpersonal Psychotherapy for Posttraumatic Stress Disorder Endure? Can J Psychiatry. 2018 Jan;63(1):37-43. doi: 10.1177/0706743717720690. Epub 2017 Jul 25.
- Suarez-Jimenez B, Zhu X, Lazarov A, Mann JJ, Schneier F, Gerber A, Barber JP, Chambless DL, Neria Y, Milrod B, Markowitz JC. Anterior hippocampal volume predicts affect-focused psychotherapy outcome. Psychol Med. 2020 Feb;50(3):396-402. doi: 10.1017/S0033291719000187. Epub 2019 Feb 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #5660, R01 MH079078
- R01MH079078 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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