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Comparative Effectiveness of Two Treatments for Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT02586064
Recruitment Status : Recruiting
First Posted : October 26, 2015
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
Georgetown University
Southeast Louisiana Veterans Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Interpersonal Therapy for PTSD Behavioral: Prolonged Exposure Not Applicable

Detailed Description:
The strong relationship between posttraumatic stress disorder (PTSD) and interpersonal problems is well documented. PTSD is highly associated with relationship discord, increased intimate partner violence, and difficulties in connecting with others, leading to social isolation. These types of conflicts, as well as the social withdrawal that is common among Veterans with PTSD, diminish the Veteran's opportunities for interaction with supportive others, and serve as a barrier to successful posttraumatic adjustment. Treatments that have been "rolled out" nationally in VAMCs, e.g., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties. Furthermore, data show that only a limited number of Veterans has fully engaged with these interventions. Evidence-based interventions of couples therapy are available, but are not logistically feasible for many couples and do not address the problems of those who are socially isolated. This application proposes a randomized clinical trial of Interpersonal Psychotherapy (IPT-PTSD) as a treatment for Veterans with PTSD and relationship problems. Pilot data suggest that this type of treatment may provide a useful alternative strategy for Veterans who would prefer an individual, relationship-focused approach. The investigators propose comparing IPT-PTSD with Prolonged Exposure (PE), an evidence based treatment for PTSD used in the VHA system. The investigators hypothesize that IPT-PTSD will be statistically equivalent to PE in reducing PTSD symptom severity, and superior to PE in improving interpersonal functioning. IPT-PTSD is also hypothesized to be more effective than PE in improving social adjustment and quality of life. Exploratory analyses will examine whether IPT-PTSD is more effective than PE in reducing suicidal ideation, and will examine hypothesized mediators of improvement in PTSD symptoms in IPT-PTSD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interpersonal Therapy for Veterans With PTSD
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: IPT-PTSD
Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions
Behavioral: Interpersonal Therapy for PTSD
Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.

Active Comparator: PE
Exposure based intervention including exposure to memories and avoided places and activities
Behavioral: Prolonged Exposure
Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).




Primary Outcome Measures :
  1. Change in Inventory of Interpersonal Functioning (IIP) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment ]
    Self-report measure of interpersonal difficulties

  2. Change in Clinician Administered PTSD Scale (CAPS-5) [ Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment ]
    Structured interview for assessment of DSM-5 PTSD symptoms


Secondary Outcome Measures :
  1. Change in Patient Health Questionnaire (PHQ) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment ]
    self report measure of mood and anxiety symptoms

  2. Change in Work and Social Adjustment Scale (WSAS) [ Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment ]
    Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships)

  3. Change in Multidimensional Scale of Perceived Social Support (MSPSS) [ Time Frame: Pretreatment, week 12 (end of treatment), 3 and 6 months posttreatment ]
    Self-report measure of subjective social support

  4. Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) [ Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment ]
    Measure of four domains related to quality of life: physical health, psychological, social relationships and environment

  5. Change in Concise Health Tracking Scale [ Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment ]
    Self report measure of suicidal ideation, hopelessness, interpersonal attachment and social support

  6. Change in PTSD checklist for DSM-5 [ Time Frame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment ]
    Self report measure of DSM-5 PTSD symptoms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans age 18 or older
  • Experienced trauma while deployed to a war zone
  • Meet DSM-5 criteria for PTSD and a minimum CAPS-5 score of 23
  • Have at least one area of relationship dysfunction
  • Consent to be randomized

Exclusion Criteria:

  • Current severe substance use disorder
  • Current psychotic symptoms
  • Current mania or un-medicated Bipolar Disorder
  • Imminent threat of suicide or homicide
  • Victim or perpetrator of severe domestic violence in the past 12 months
  • Currently receiving Cognitive Behavioral Therapy for PTSD
  • Psychotropic medication start or dosage change within the prior 4 weeks

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 ClinicalTrials.gov identifier (NCT number): NCT02586064


Contacts
Contact: Tracie M Shea, PhD Tracie.Shea@va.gov
Contact: Elizabeth B Sevin, LCSW-C (401) 273-7100 ext 6280 Elizabeth.Sevin@va.gov

Locations
United States, Louisiana
Southeast Louisiana Veterans Health Care System, New Orleans, LA Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Frederic Sautter, PhD    504-571-8292    Sautter.Frederic@va.gov   
Contact: Julia Cretu    5045718320    Julia.Cretu2@va.gov   
United States, Rhode Island
Providence VA Medical Center, Providence, RI Recruiting
Providence, Rhode Island, United States, 02908
Contact: Candace M Shuman    401-273-7100 ext 3872    Candace.Shuman@va.gov   
Contact: Kimberly Marcolivio, MEd    (401) 273-7100 ext 3464    Kimberly.Marcolivio@va.gov   
Principal Investigator: Tracie M. Shea, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Georgetown University
Southeast Louisiana Veterans Health Care System
Investigators
Principal Investigator: Tracie M. Shea, PhD Providence VA Medical Center, Providence, RI

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02586064     History of Changes
Other Study ID Numbers: D1783-R
I01RX001783 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
posttraumatic stress disorder
Veterans
Psychotherapy
Randomized Controlled Trial

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