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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

Psychotherapies for Chronic Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739765
• Other study ID #: #5660, R01 MH079078
• Secondary ID: R01MH079078
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: March 2014

Study information

• Verified date: February 2019
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

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

Markowitz JC. IPT and PTSD. Depress Anxiety. 2010 Oct;27(10):879-81. doi: 10.1002/da.20752. — View Citation

Rafaeli AK, Markowitz JC. Interpersonal psychotherapy (IPT) for PTSD: a case study. Am J Psychother. 2011;65(3):205-23. — View 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. 2019 Feb 18:1-7. doi: 10.1017/S00332917190 — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	After 14 weeks of treatment
Secondary	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	After 14 weeks of treatment

External Links

•   Click here for more information on trauma and PTSD at the Web site of Columbia University Medical Center, New York State Psychiatric Institute