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Post-Traumatic Stress DisorderNCT00739765

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

A study testing Interpersonal Psychotherapy, Prolonged Exposure Therapy and Relaxation Therapy in people with Post-Traumatic Stress Disorder, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post-Traumatic Stress Disorder
What is being tested?
Interpersonal Psychotherapy, Prolonged Exposure Therapy and Relaxation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
Apr 2008to Mar 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York State Psychiatric Institute

    New York, New York, 10032

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Interpersonal Psychotherapy, Prolonged Exposure Therapy, Relaxation Therapy
Keywords
Trauma, Psychotherapy, Anxiety
Medical subject headings
Stress Disorders, Post-Traumatic, Wounds and Injuries, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interpersonal PsychotherapyBehavioural

    14 weekly 50-minute sessions of interpersonal psychotherapy, a time-limited treatment that focuses on interpersonal functioning and social supports

  • Prolonged Exposure TherapyBehavioural

    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

  • Relaxation TherapyBehavioural

    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

Study groups in NCT00739765
Study groupRoleWhat they receive
1 Interpersonal Psychotherapy (IPT)ExperimentalParticipants will receive interpersonal psychotherapy.
Receives: Behavioral: Interpersonal Psychotherapy
2 Prolonged Exposure (PE)Active comparatorParticipants will receive prolonged exposure therapy.
Receives: Behavioral: Prolonged Exposure Therapy
3 Relaxation therapyActive comparatorParticipants will receive relaxation therapy.
Receives: Behavioral: Relaxation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: After 14 weeks of treatment

Secondary outcomes (1)
  1. 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

    Measured: After 14 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionMar 2013
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial of three time-limited (14 week) psychotherapies for unmedicated patients with chronic posttraumatic stress disorder (PTSD)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00739765
Sponsor's protocol ID
#5660, R01 MH079078
Other IDs
R01MH079078
Status last verified
Apr 2026
First submitted
20 Aug 2008
Last updated
12 May 2026
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 15625219
  • 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.

    PubMed 16462550
  • 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.

    PubMed 12699027
  • 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.

    PubMed 19339847
  • 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.

    PubMed 22759936
  • 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.

    PubMed 22476306
  • 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.

    PubMed 22032045
  • 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.

    PubMed 21297048
  • Markowitz JC. IPT and PTSD. Depress Anxiety. 2010 Oct;27(10):879-81. doi: 10.1002/da.20752. No abstract available.

    PubMed 20886608
  • 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.

    PubMed 24493661
  • 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.

    PubMed 25677355
  • 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.

    PubMed 26115532
  • 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.

    PubMed 26439430
  • 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.

    PubMed 28376282
  • 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.

    PubMed 28743198

Questions about this trial

What is this clinical trial studying?

A study testing Interpersonal Psychotherapy, Prolonged Exposure Therapy and Relaxation Therapy in people with Post-Traumatic Stress Disorder, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-Administered PTSD Scale (CAPS) (time frame: After 14 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00739765, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

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