Comparative Effectiveness of Two Treatments for Veterans With PTSD

Posttraumatic Stress Disorder Clinical Trial

Official title:

Interpersonal Therapy for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586064
• Other study ID #: D1783-R
• Secondary ID: I01RX001783
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: June 2021
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Southeast Louisiana Veterans Health Care System, New Orleans, LA	New Orleans	Louisiana
United States	Providence VA Medical Center, Providence, RI	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	Georgetown University, Southeast Louisiana Veterans Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinician Administered PTSD Scale (CAPS-5)	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.	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
Primary	Change in Inventory of Interpersonal Functioning (IIP-32)	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.	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	Change in PTSD Checklist for DSM-5 Military Version (PCL-M)	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.	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
Secondary	Change in Patient Health Questionnaire (PHQ)	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.	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	Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other	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.	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
Secondary	Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family	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.	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
Secondary	Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends	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.	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
Secondary	Change in Concise Health Risk Tracking Scale - Total (CHRT)	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.	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
Secondary	Change in Concise Health Risk Tracking Scale (CHRT) - Propensity	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.	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
Secondary	Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts	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.	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
Secondary	Change in Work and Social Adjustment Scale (WSAS)	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.	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
Secondary	Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life	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.	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.
Secondary	Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health	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.	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.
Secondary	GAD - 7 Generalized Anxiety Disorder	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.	Baseline to 6 months posttreatment