Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
Prolonged Exposure Therapy
Relaxation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Trauma, Psychotherapy, Anxiety
Eligibility Criteria
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
1 Interpersonal Psychotherapy (IPT)
2 Prolonged Exposure (PE)
3 Relaxation therapy
Arm Description
Participants will receive interpersonal psychotherapy.
Participants will receive prolonged exposure therapy.
Participants will receive relaxation therapy.
Outcomes
Primary Outcome Measures
Clinician-Administered PTSD Scale (CAPS)
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
Secondary Outcome Measures
Hamilton Depression Rating Scale
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
Full Information
NCT ID
NCT00739765
First Posted
August 20, 2008
Last Updated
February 20, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00739765
Brief Title
Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
Official Title
Psychotherapies for Chronic Post-Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
Trauma, Psychotherapy, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial of three time-limited (14 week) psychotherapies for unmedicated patients with chronic posttraumatic stress disorder (PTSD)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Interpersonal Psychotherapy (IPT)
Arm Type
Experimental
Arm Description
Participants will receive interpersonal psychotherapy.
Arm Title
2 Prolonged Exposure (PE)
Arm Type
Active Comparator
Arm Description
Participants will receive prolonged exposure therapy.
Arm Title
3 Relaxation therapy
Arm Type
Active Comparator
Arm Description
Participants will receive relaxation therapy.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS)
Description
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
Secondary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
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
Time Frame
After 14 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Markowitz, MD
Organizational Affiliation
New York State Psychiatric Institution
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
15625219
Citation
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.
Results Reference
background
PubMed Identifier
16462550
Citation
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.
Results Reference
background
PubMed Identifier
12699027
Citation
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.
Results Reference
background
PubMed Identifier
19339847
Citation
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.
Results Reference
background
PubMed Identifier
22759936
Citation
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.
Results Reference
background
PubMed Identifier
22476306
Citation
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.
Results Reference
background
PubMed Identifier
22032045
Citation
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.
Results Reference
background
PubMed Identifier
21297048
Citation
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.
Results Reference
background
PubMed Identifier
20886608
Citation
Markowitz JC. IPT and PTSD. Depress Anxiety. 2010 Oct;27(10):879-81. doi: 10.1002/da.20752. No abstract available.
Results Reference
background
PubMed Identifier
24493661
Citation
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.
Results Reference
background
PubMed Identifier
25677355
Citation
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.
Results Reference
result
PubMed Identifier
26115532
Citation
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.
Results Reference
result
PubMed Identifier
26439430
Citation
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.
Results Reference
result
PubMed Identifier
28376282
Citation
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.
Results Reference
result
PubMed Identifier
28743198
Citation
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.
Results Reference
result
PubMed Identifier
30773148
Citation
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.
Results Reference
result
Links:
URL
http://www.columbiatrauma.org/
Description
Click here for more information on trauma and PTSD at the Web site of Columbia University Medical Center, New York State Psychiatric Institute
Learn more about this trial
Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
We'll reach out to this number within 24 hrs