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

NCT00739765 | Completed Results DMC

• 2 other identifiers: #5660, R01 MH079078R01MH079078
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Traumatic Stress Disorder

Keywords

Trauma; Psychotherapy; Anxiety

Outcome Measures

Primary Outcomes (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

  After 14 weeks of treatment

Secondary Outcomes (1)

• Hamilton Depression Rating Scale

  After 14 weeks of treatment

Study Arms (3)

1 Interpersonal Psychotherapy (IPT)

EXPERIMENTAL

Participants will receive interpersonal psychotherapy.

Behavioral: Interpersonal Psychotherapy

2 Prolonged Exposure (PE)

ACTIVE COMPARATOR

Participants will receive prolonged exposure therapy.

Behavioral: Prolonged Exposure Therapy

3 Relaxation therapy

ACTIVE COMPARATOR

Participants will receive relaxation therapy.

Behavioral: Relaxation Therapy

Interventions

Interpersonal Psychotherapy BEHAVIORAL

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

1 Interpersonal Psychotherapy (IPT)

Prolonged Exposure Therapy BEHAVIORAL

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

2 Prolonged Exposure (PE)

Relaxation Therapy BEHAVIORAL

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

3 Relaxation therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (16)

• 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.

  PMID: 15625219 BACKGROUND

• 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.

  PMID: 16462550 BACKGROUND

• 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.

  PMID: 12699027 BACKGROUND

• 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.

  PMID: 19339847 BACKGROUND

• 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.

  PMID: 22759936 BACKGROUND

• 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.

  PMID: 22476306 BACKGROUND

• 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.

  PMID: 22032045 BACKGROUND

• 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.

  PMID: 21297048 BACKGROUND

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

  PMID: 20886608 BACKGROUND

• 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.

  PMID: 24493661 BACKGROUND

• 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.

  PMID: 25677355 RESULT

• 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.

  PMID: 26115532 RESULT

• 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.

  PMID: 26439430 RESULT

• 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.

  PMID: 28376282 RESULT

• 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.

  PMID: 28743198 RESULT

• 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. 2020 Feb;50(3):396-402. doi: 10.1017/S0033291719000187. Epub 2019 Feb 18.

  PMID: 30773148 RESULT

Related Links

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

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries; Anxiety Disorders

Interventions

Interpersonal Psychotherapy; Relaxation Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy

Limitations and Caveats

Limited generalizability of unmedicated sample; incomplete therapist fidelity rating; limited sample size.

Results Point of Contact

• Title: John C. Markowitz, M.D.
• Organization: New York State Psychiatric Institute

jcm42@cumc.columbia.edu

646 774-8098

Study Officials

• John C. Markowitz, MD

  New York State Psychiatric Institution

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychiatrist

Model Details: Randomized controlled trial of three time-limited (14 week) psychotherapies for unmedicated patients with chronic posttraumatic stress disorder (PTSD)

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 5, 2019
• Results First Posted: November 16, 2015

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)