Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00739765

Purpose

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

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Psychotherapies for Chronic Post-Traumatic Stress Disorder

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Clinician-Administered PTSD Scale (CAPS) [ Time Frame: After 14 weeks of treatment and at a 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hamilton Depression Rating Scale [ Time Frame: After 14 weeks of treatment and at a 3-month follow-up ] [ Designated as safety issue: No ]

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739765

Contacts

Contact: Helena Rosenfeld

212-543-6747

Helena@nyspi.cpmc.columbia.edu

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

John C. Markowitz, MD

New York State Psychiatric Institution

More Information

Click here for more information on trauma and PTSD at the Web site of Columbia University Medical Center, New York State Psychiatric Institute This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Bleiberg KL, Markowitz JC. A pilot study of interpersonal psychotherapy for posttraumatic stress disorder. Am J Psychiatry. 2005 Jan;162(1):181-3.

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.

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.

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

Keywords provided by National Institute of Mental Health (NIMH):

Trauma
Psychotherapy
Anxiety

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Wounds and Injuries

Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009