Actively Recruiting
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Led by Boston University · Updated on 2026-04-01
54
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether adding an intervention called Adjunctive Writing to Amplify Response and Engagement (AWARE) can improve outcomes for adults with posttraumatic stress disorder (PTSD) receiving established therapies. The study focuses on two effective treatments for PTSD: cognitive processing therapy (CPT) and prolonged exposure (PE). AWARE is designed to enhance communication between patients and therapists about treatment experiences, potentially leading to better treatment results. The study includes a first phase to pilot test AWARE with a small group and a second phase as a randomized controlled trial comparing AWARE-enhanced therapy to standard therapy without AWARE. Participants will receive either CPT or PE, choosing their preferred therapy, delivered in 8 to 15 weekly sessions. In the first phase, four adults will receive CPT or PE with the AWARE writing intervention, which involves brief writing tasks about treatment experiences and guided therapist discussions. In the second phase, 50 adults will be randomly assigned to receive either CPT/PE with AWARE or CPT/PE as usual. The study aims to assess how acceptable and feasible AWARE is, and whether it improves communication and treatment outcomes compared to usual care. Throughout the study, participants will be evaluated immediately after treatment and three months later. Researchers will measure patient-provider communication, PTSD symptoms, therapy adherence and competence, client satisfaction, therapeutic alliance, treatment completion, depression, and functional impairment. Assessments include standardized interviews and questionnaires. This study is expected to last until December 2028, with Boston University leading the research.
CONDITIONS
Brief Title
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of PTSD
- Stable on psychiatric medications for at least 4 weeks
- Adults aged 18 years and older
You will not qualify if you...
- Current unstable bipolar disorder
- Current psychosis
- Current active suicidal or homicidal ideation with intent or plan
- Current severe substance use that requires immediate medical attention
- Currently receiving trauma-focused treatment
- Significant cognitive impairment preventing participation in therapy and assessments (e.g., advanced dementia, severe traumatic brain injury)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 15 weeks
Participants receive cognitive processing therapy (CPT) or prolonged exposure (PE) therapy, with some also receiving an adjunctive writing intervention (AWARE) to enhance engagement. Treatment involves weekly sessions focusing on processing traumatic experiences.
Weekly visits for 8 to 15 weeks
Duration - 3 months
Participants are assessed to monitor PTSD symptoms and treatment outcomes following the completion of therapy.
1 visit (in-person) approximately 3 months after treatment ends
Trial Site Locations
Total: 1 location
1
National Center for PTSD at VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Actively Recruiting
Research Team
E
Elizabeth Alpert, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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