Comparative Effectiveness of Two Treatments for Veterans With PTSD

• ClinicalTrials.gov Identifier: NCT02586064
• Recruitment Status: Completed
• First Posted: October 26, 2015
• Results First Posted: July 7, 2021
• Last Update Posted: July 7, 2021
• Sponsor: VA Office of Research and Development
• Collaborators: Georgetown University; Southeast Louisiana Veterans Health Care System
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 115 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Interpersonal Therapy for Veterans With PTSD
• Actual Study Start Date: September 1, 2016
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: March 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Interpersonal Psychotherapy for 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: Prolonged Exposure; 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).

Outcome Measures

Primary Outcome Measures :

1. Change in Clinician Administered PTSD Scale (CAPS-5) [ Time Frame: 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.

2. Change in Inventory of Interpersonal Functioning (IIP-32) [ Time Frame: 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 :

1. Change in PTSD Checklist for DSM-5 Military Version (PCL-M) [ Time Frame: 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.

2. Change in Patient Health Questionnaire (PHQ) [ Time Frame: 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.

3. Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other [ Time Frame: 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.

4. Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family [ Time Frame: 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.

5. Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends [ Time Frame: 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.

6. Change in Concise Health Risk Tracking Scale - Total (CHRT) [ Time Frame: 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.

7. Change in Concise Health Risk Tracking Scale (CHRT) - Propensity [ Time Frame: 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.

8. Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts [ Time Frame: 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.
9. Change in Work and Social Adjustment Scale (WSAS) [ Time Frame: 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.

10. Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life [ Time Frame: 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.

11. Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health [ Time Frame: 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.

12. GAD - 7 Generalized Anxiety Disorder [ Time Frame: 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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Louisiana

Southeast Louisiana Veterans Health Care System, New Orleans, LA

New Orleans, Louisiana, United States, 70112

United States, Rhode Island

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, United States, 02908

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

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] September 18, 2018

Informed Consent Form  [PDF] April 18, 2019

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02586064
• Other Study ID Numbers: D1783-R; I01RX001783 ( U.S. NIH Grant/Contract )
• First Posted: October 26, 2015
• Results First Posted: July 7, 2021
• Last Update Posted: July 7, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: not developed yet
• Supporting Materials: Study Protocol
• Time Frame: Following publication of primary and secondary study findings
• Access Criteria: uncertain at this point

• 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; Treatment

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders