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

Not Applicable

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Interpersonal Psychotherapy; Behavioral: Prolonged Exposure Therapy; Behavioral: Relaxation Therapy

• Registration Number: NCT00739765
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-08-20
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-22
• Primary Completion: 2013-03
• Study Completion: 2014-03
• Results First Submitted: 2015-09-08
• Results First Submitted QC: 2015-10-13
• Results First Posted: 2015-11-16
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Interpersonal Psychotherapy (IPT)	Interpersonal Psychotherapy	Participants will receive interpersonal psychotherapy.
2 Prolonged Exposure (PE)	Prolonged Exposure Therapy	Participants will receive prolonged exposure therapy.
3 Relaxation therapy	Relaxation Therapy	Participants will receive relaxation therapy.

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale (CAPS)	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

Name	Time	Method
Hamilton Depression Rating Scale	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

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States