Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06088303

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of PTSD
  • Stable on psychiatric medications for at least 4 weeks
  • Adults aged 18 years and older
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

Follow-up

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

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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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