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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00739765
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : November 16, 2015
Last Update Posted : August 21, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Interpersonal Psychotherapy Behavioral: Prolonged Exposure Therapy Behavioral: Relaxation Therapy Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Psychotherapies for Chronic Post-Traumatic Stress Disorder
Study Start Date : April 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Interpersonal Psychotherapy (IPT)
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
Active Comparator: 2 Prolonged Exposure (PE)
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
Active Comparator: 3 Relaxation therapy
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

Primary Outcome Measures :
  1. Clinician-Administered PTSD Scale (CAPS) [ Time Frame: After 14 weeks of treatment ]
    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 :
  1. Hamilton Depression Rating Scale [ Time Frame: After 14 weeks of treatment ]
    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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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00739765

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Principal Investigator: John C. Markowitz, MD New York State Psychiatric Institution

Additional Information:
Publications of Results:
Other Publications:

Responsible Party: New York State Psychiatric Institute Identifier: NCT00739765     History of Changes
Other Study ID Numbers: #5660, R01 MH079078
R01MH079078 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2008    Key Record Dates
Results First Posted: November 16, 2015
Last Update Posted: August 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by New York State Psychiatric Institute:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders