NCT03533608

Optimizing Treatment Response in VA Specialized Intensive/Inpatient PTSD Programs

Completed NA Results posted Last updated 25 July 2023

What this trial tests

NA trial testing Group PE in PTSD in 39 participants. Completed in 15 March 2020.

Timeline

1 June 2018

Primary endpoint
15 March 2020

15 March 2020

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	1 June 2018
Primary completion	15 March 2020
Estimated completion	15 March 2020
Sites	2 locations across United States

Drugs / interventions tested

• Group PE

Conditions studied

• PTSD — all drugs for PTSD →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with PTSD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in PTSD Symptoms Primary · Baseline, 6-week, and 2-months

PTSD symptoms will be measured via the PCL-5 at baseline, 6-week, and 2-months. The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Patients are asked to rate how bothered they are by each item in the past month on a 5-point likert scale ranging from 0-4 (not at all, a little bit, moderately, quite a bit, extremely). Items are summed together and a PCL-5 cut point score of 33 is used for provisional PTSD diagnosis. Change = (Week 6 score-Baseline score) and (2 month score-Baseline score).

Change in Baseline to 6-weeks

Group	Value	95% CI
Group PE	-23.86	± 13.81

Change in Baseline to 2-months

Group	Value	95% CI
Group PE	-19.51	± 13.81

Change in Depression Symptoms Primary · Baseline, 6 weeks, 2-months

Depressive symptoms will be measured via the PHQ-9 at baseline, 6-weeks, and 2-months. The PHQ-9 is a 9-item self-report measure that assesses the presence and severity of depressive symptoms. Patients are asked to rate the presence of symptoms over the past 2 weeks on a 4-point likert scale ranging from 0-3 (not at all, several days, more than half the days, nearly every day). Individual items are summed together and Total scores ranging from 5-9 indicate mild depression, 10-14 indicate moderate depression, 15-19 indicate moderately severe depression, and 20-27 indicate severe depression. Cha

Change from baseline to 6-weeks

Group	Value	95% CI
Group PE	-4.68	± 4.51

Change from baseline to 2-months

Group	Value	95% CI
Group PE	-4.04	± 4.51

Sponsor's own description

Prolonged Exposure therapy (PE) is a first-line treatment for posttraumatic stress disorder; however few VA patients receive this treatment. One of the barriers to PE receipt is that this treatment is only available in an individual (one-on-one) format, whereas many VA mental health clinics provide the majority of their psychotherapy services in group format. In particular, PTSD residential rehabilitation programs (RRTPs) offer most programming in group format. Thus, the current study was designed to pilot test a group format of PE in RRTPs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.