Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
This study is currently recruiting participants.
Study NCT00739765   Information provided by National Institute of Mental Health (NIMH)
First Received: August 20, 2008   Last Updated: March 10, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

August 20, 2008
March 10, 2009
April 2008
Clinician-Administered PTSD Scale (CAPS) [ Time Frame: After 14 weeks of treatment and at a 3-month follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739765 on ClinicalTrials.gov Archive Site
Hamilton Depression Rating Scale [ Time Frame: After 14 weeks of treatment and at a 3-month follow-up ] [ Designated as safety issue: No ]
Same as current
 
Effectiveness of Three Different Psychotherapies for Chronic Post-Traumatic Stress Disorder
Psychotherapies for Chronic Post-Traumatic Stress Disorder

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.

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.
Phase III
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Post-Traumatic Stress Disorder
  • Behavioral: Interpersonal Psychotherapy
  • Behavioral: Prolonged Exposure Therapy
  • Behavioral: Relaxation Therapy
  • Experimental: Participants will receive interpersonal psychotherapy.
  • Active Comparator: Participants will receive prolonged exposure therapy.
  • Active Comparator: Participants will receive relaxation therapy.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
165
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Helena Rosenfeld 212-543-6747 Helena@nyspi.cpmc.columbia.edu
United States
 
 
NCT00739765
John C. Markowitz, MD, Research Psychiatrist, Research Foundation for Mental Health/New York State Psychiatric Institute
DATR AD-TS
National Institute of Mental Health (NIMH)
 
Principal Investigator: John C. Markowitz, MD New York State Psychiatric Institution
National Institute of Mental Health (NIMH)
March 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.