Clinical trial NCT02586064: Comparative Effectiveness of Two Treatments for Veterans With PTSD
Official title: Interpersonal Therapy for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
Veterans
Psychotherapy
Randomized Controlled Trial
Treatment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Georgetown University
name: Southeast Louisiana Veterans Health Care System
First posted: 2015-10-26
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Clinician Administered PTSD Scale (CAPS-5)
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Inventory of Interpersonal Functioning (IIP-32)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
Secondary outcomes:
measure: Change in PTSD Checklist for DSM-5 Military Version (PCL-M)
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Patient Health Questionnaire (PHQ)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Concise Health Risk Tracking Scale - Total (CHRT)
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Concise Health Risk Tracking Scale (CHRT) - Propensity
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
measure: Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life
timeFrame: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
measure: Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health
timeFrame: Difference between Baseline and End of Treatment means. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks.
measure: GAD - 7 Generalized Anxiety Disorder
timeFrame: Baseline to 6 months posttreatment
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System, New Orleans, LA
state: Louisiana
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Tracie M. Shea, PhD
role: PRINCIPAL_INVESTIGATOR
References: