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Comparative Effectiveness of Two Treatments for Veterans With PTSD

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VA Office of Research and Development

Status

Completed

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Prolonged Exposure
Behavioral: Interpersonal Therapy for PTSD

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02586064
I01RX001783 (U.S. NIH Grant/Contract)
D1783-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

115 participants in 2 patient groups

Interpersonal Psychotherapy for PTSD
Experimental group
Description:
Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions
Treatment:
Behavioral: Interpersonal Therapy for PTSD
Prolonged Exposure
Active Comparator group
Description:
Exposure based intervention including exposure to memories and avoided places and activities
Treatment:
Behavioral: Prolonged Exposure

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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