Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06088303

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

Led by Boston University · Updated on 2026-04-01

54

Participants Needed

1

Research Sites

202 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

The purpose of this clinical trial is to learn whether existing treatments for posttraumatic stress disorder (PTSD) can be improved. Two treatments for PTSD, cognitive processing therapy (CPT) and prolonged exposure (PE) will be studied. CPT and PE are effective treatments that are widely available, but interventions are needed to improve patient outcomes in these treatments. The investigators have developed an Adjunctive Writing intervention for Amplifying Response and Engagement (AWARE), which was designed using health communication strategies to enhance CPT and PE by improving communication between patients and therapists about patients' experiences in treatment. This research will investigate whether adding AWARE to CPT and PE will lead to better treatment outcomes compared to CPT and PE provided as usual without AWARE. AWARE includes a brief writing task asking patients about their experiences in treatment, as well as guided therapist responses to improve patient-therapist communication about patients' experiences in treatment. In the first phase of the study (case series phase), CPT or PE with AWARE will be provided to four adults with PTSD to pilot test adding AWARE to CPT and PE, seek patient and provider feedback, and refine AWARE. The first four participants who enroll will be part of the case series and will receive CPT or PE with AWARE. Then, in the second phase of the study, the randomized controlled trial (RCT) phase, the investigators will enroll 50 more adults with PTSD who will be randomly assigned (like flipping a coin) to receive CPT/PE as usual or CPT/PE with AWARE. It is expected that 25 participants will be randomized to CPT/PE with AWARE and 25 participants will be randomized to receive CPT/PE provided as usual. The goals of the RCT phase are to study whether AWARE is acceptable to patients, whether it is feasible to add AWARE to CPT and PE, and whether adding AWARE to CPT and PE improves patient-therapist communication and treatment outcomes compared to CPT/PE as usual.

CONDITIONS

Official 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
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 warrants immediate medical attention
  • Current trauma-focused treatment
  • Significant cognitive impairment that would prevent engagement in assessments and therapy (e.g., advanced dementia, severe traumatic brain injury).

AI-Screening

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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

CONTACT

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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