Comparative Effectiveness of Two Treatments for Veterans With PTSD

Not Applicable

Completed

Conditions: Posttraumatic Stress Disorder

Interventions: Behavioral: Interpersonal Therapy for PTSD
Behavioral: Prolonged Exposure

Registration Number: NCT02586064

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal Psychotherapy for PTSD	Interpersonal Therapy for PTSD	Relationally-focused intervention addressing PTSD symptoms and relationship dysfunctions, 12 weekly sessions
Prolonged Exposure	Prolonged Exposure	Exposure based intervention including exposure to memories and avoided places and activities

Primary Outcome Measures

Name	Time	Method
Change in Clinician Administered PTSD Scale (CAPS-5)	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	Structured interview for assessment of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.
Change in Inventory of Interpersonal Functioning (IIP-32)	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	Self-report measure of Veterans' interpersonal difficulties. Scores range from a minimum value of 0 to a maximum value of 128, higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other	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	Self-report measure of a participant's subjective social support with regards to a participant's significant other. For each subscale, the mean of items is reported therefore for the Significant Other Subscale: Sum across items 1, 2, 5, \& 10, then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
Change in Concise Health Risk Tracking Scale (CHRT) - Propensity	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	The propensity subscale score includes 9 items assessing, hopelessness, self-worth and perceived social support, and the possible range for our study is 9 to 45 Higher scores indicate worse outcome.
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life	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 of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 1 (Quality of Life) Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.
GAD - 7 Generalized Anxiety Disorder	Baseline to 6 months posttreatment	Measure of generalized anxiety amongst participants over time. Scores range from a minimum value of 0 to a maximum value of 21, higher scores mean a worse outcome.
Change in Concise Health Risk Tracking Scale - Total (CHRT)	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	Self report measure of suicidal ideation and related symptoms. Our study used a response scale of 1 to 5. The CHRT has 12 items, and the total score has a possible range of 12 to 60. Higher scores indicate more suicidal ideation and risk.
Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health	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 of four domains related to quality of life: physical health, psychological, social relationships and environment. Data presented from Item 2 (Satisfaction with Health). Scores range from a minimum value of 1 to a maximum value of 5, lower scores mean a worse outcome.
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family	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	Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Family Subscale: Sum across items 3, 4, 8, \& 11 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends	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	Self-report measure of a participant's subjective social support with regards to a participant's family. For each subscale, the mean of items is reported therefore for the Friends Subscale: Sum across items 6, 7, 9, \& 12 then divide by 4.Range can be from 1 - 7. Lower scores mean a worse outcome.
Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts	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	The CHRT Suicidal Thoughts subscale includes 3 items and has a possible range in our study from 3 to 15. Higher scores indicate higher suicidal thoughts.
Change in Patient Health Questionnaire (PHQ)	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	Self report measure of mood and anxiety symptoms. Scores range from a minimum value of 0 to a maximum value of 27, higher scores mean a worse outcome.
Change in PTSD Checklist for DSM-5 Military Version (PCL-M)	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	Self report measure of DSM-5 PTSD symptoms. Scores range from a minimum value of 0 to a maximum value of 80, higher scores mean a worse outcome.
Change in Work and Social Adjustment Scale (WSAS)	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	Self report measure of functional impairment in five areas of functioning (work, home management, social leisure, personal leisure, close relationships. Scores range from a minimum value of 0 to a maximum value of 40, higher scores mean a worse outcome.

Trial Locations

Locations (2): Southeast Louisiana Veterans Health Care System, New Orleans, LA
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New Orleans, Louisiana, United States
Providence VA Medical Center, Providence, RI
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Providence, Rhode Island, United States