Improving PTSD Treatment with Communication Strategies
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Recruiting
N/AInterventional Study
Stress Disorders, Post-Traumatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
54 (estimated)
Sponsor
Boston University · Other
Who this trial is looking for
This trial is looking for adults diagnosed with PTSD to test a new way to improve existing treatments. Participants will add a writing task to their usual therapy to see if it helps them communicate better with their therapists.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with PTSD
I have been stable on psychiatric medications for at least 4 weeks
You may not be able to join if
I have current unstable bipolar disorder
I have current psychosis
I have current active suicidal or homicidal thoughts with intent or plan
I have current severe substance use that needs immediate medical attention
I am currently in trauma-focused treatment
I have significant cognitive impairment that prevents me from engaging in assessments and therapy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 hav…
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.
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Eligibility Criteria
Inclusion Criteria:
* Diagnosis of PTSD
* Stable on psychiatric medications for at least 4 weeks
Exclusion Criteria:
* Current unstable bipolar disorder
* Current psychosis
* Current active suicidal or homicidal ideation with intent or plan
* Current severe substance use that warrants immediate m…
Inclusion Criteria:
* Diagnosis of PTSD
* Stable on psychiatric medications for at least 4 weeks
Exclusion Criteria:
* 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).
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