N/A N=115 Randomized Double-blind Treatment

Comparative Effectiveness of Two Treatments for Veterans With PTSD

Posttraumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02586064 ↗

Enrolled (actual)

115

Serious AEs

9.6%

Results posted

Jul 2021

Primary outcome: Primary: Change in Clinician Administered PTSD Scale (CAPS-5) — 36.3; 34.8; 1.52; 27.8 score on a scale — p=0.28

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Interpersonal Therapy for PTSD (Behavioral); Prolonged Exposure (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Clinician Administered PTSD Scale (CAPS-5)	36.3; 34.8; 1.52; 27.8; 28.2; -0.43	0.28
PRIMARY Change in Inventory of Interpersonal Functioning (IIP-32)	1.53; 1.43; 0.11; 1.5; 1.4; 0.13	0.36
SECONDARY Change in PTSD Checklist for DSM-5 Military Version (PCL-M)	48.0; 45.8; 2.15; 33.7; 35.5; -1.82	0.40
SECONDARY Change in Patient Health Questionnaire (PHQ)	15.2; 13.0; 2.15; 13.9; 12.9; 1.0	0.11
SECONDARY Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Significant Other	4.9; 5.5; -0.56; 4.9; 5.7; -0.74	0.08
SECONDARY Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Family	3.9; 4.6; -0.66; 4.4; 5.1; -0.75	0.05
SECONDARY Change in Multidimensional Scale of Perceived Social Support (MSPSS) - Friends	3.9; 4.1; -0.23; 4.4; 4.3; 0.14	0.45
SECONDARY Change in Concise Health Risk Tracking Scale - Total (CHRT)	27.6; 25.7; 1.87; 25.4; 21.9; 3.49	0.35
SECONDARY Change in Concise Health Risk Tracking Scale (CHRT) - Propensity	22.8; 21.4; 1.40; 20.6; 17.9; 2.68	0.39
SECONDARY Change in Concise Health Risk Tracking Scale (CHRT) - Suicidal Thoughts	4.8; 4.3; 0.47; 4.8; 4.0; 0.81	0.33
SECONDARY Change in Work and Social Adjustment Scale (WSAS)	24.0; 22.6; 2.40; 20.4; 15.8; 4.58	0.16
SECONDARY Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 1 Quality of Life	3.1; 3.3; -0.21; 3.2; 3.2; 0.05	0.24
SECONDARY Change in WHO Short Form Quality of Life Measure (WHOQOL-BREF) - Item 2 Satisfaction With Health	2.7; 2.8; -0.17; 2.6; 2.9; -0.29	0.41
SECONDARY GAD - 7 Generalized Anxiety Disorder	12.1; 11.6; 0.44; 12.2; 12.1; 0.06	0.70

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02586064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.