NCT03256227

Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families

Completed NA Results posted Last updated 14 June 2024

What this trial tests

NA trial testing Family Supported Prolonged Exposure in Posttraumatic Stress Disorder in 128 participants. Completed in 30 June 2022.

Timeline

15 January 2018

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	128
Start date	15 January 2018
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	3 locations across United States

Drugs / interventions tested

• Family Supported Prolonged Exposure
• Standard Prolonged Exposure

Conditions studied

• Posttraumatic Stress Disorder — all drugs for Posttraumatic Stress Disorder →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Posttraumatic Stress Disorder. 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.

Session Attendance Primary · 16 weeks

Number of treatment sessions attended by the participant

Group	Value	95% CI
Family Supported Prolonged Exposure	6.77	± 3.99
Standard Prolonged Exposure	5.56	± 4.16

PTSD Checklist for DSM-5 (PCL-5) Secondary · 16 weeks

The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Range of scale is 0-80 and can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD symptom levels.

Group	Value	95% CI
Family Supported Prolonged Exposure	51.56	± 12.60
Standard Prolonged Exposure	53.79	± 12.54

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment initiation through 3 month follow-up, up to 40 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Family Supported Prolonged Exposure

Serious: 2/64 (3%)

Deaths: 0/64

Standard Prolonged Exposure

Serious: 2/64 (3%)

Deaths: 0/64

Serious adverse events (2 terms)

Reaction	System	Family Supported Prolonged…	Standard Prolonged Exposure
Severe Suicidal ideation	Psychiatric disorders	—	—
Psychological decompisation	Psychiatric disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	Family Supported Prolonged…	Standard Prolonged Exposure
ER visit	General disorders	—	—
Hospitalization	General disorders	—	—
Mild Suicidal ideation	Psychiatric disorders	—	—

Most-reported serious reactions: Severe Suicidal ideation, Psychological decompisation.

Data from ClinicalTrials.gov NCT03256227 adverse events section.

Sponsor's own description

Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in clinically significant symptom relief for many. Yet, adherence to this treatment (i.e., session attendance and homework compliance), which is vital to ensuring recovery, can be poor. This project will test the effectiveness of improving family support for PE as a tool to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite congressional legislation and national mandates within VA/DoD for family involvement in PTSD care, there remains no proven strategies for how to routinely include family in traditional individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a model of family engagement that can be translated to other problems faced by Veterans, including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain management, contributing to a broader evolution towards evidence-based, family-inclusive care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement.
   Meis LA, Glynn SM, Spoont MR, Kehle-Forbes SM, et al · · 2022 · cited 8× · PMID 35354481 · DOI 10.1186/s13063-022-06183-2