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Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

Study acronym: AWARE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Oct 31, 2028 to Oct 2028
    • Study completion date: Dec 31, 2028 to Dec 2028
    v13
  2. Minor Re-verified, no change to tracked fieldsv12
  3. Minor Start date changed from estimate of Jan 31, 2025 to Jan 15, 2025v11
  4. Notable Trial status: Not Yet Recruiting to Recruitingv10 Show 4 more changesShow less
    • Primary completion date: Oct 2028 to Oct 31, 2028
    • Study completion date: Dec 2028 to Dec 31, 2028
    • Start date: Jan 2025 to Jan 31, 2025
    • Site details revised
  5. Minor Start date: Dec 2024 to Jan 2025v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Start date: Nov 2024 to Dec 2024v8
  2. Minor Start date: Oct 2024 to Nov 2024v7
  3. Minor Start date: Sep 2024 to Oct 2024v6
  4. Minor 2 versions Re-verified since Mar 16, 2024, no change to tracked fieldsv4-v5
  5. Notable Start date: Feb 2024 to Sep 2024v3
  6. Minor Start date: Jan 2024 to Feb 2024v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
889 trials monitored
See 54 trials at risk
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.
Trial Details
NCT Number NCT06088303
Lead Sponsor Boston University
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)
Stress Disorders, Post-Traumatic
Related terms Stress Disorders, Post-Traumatic
Enrollment 54 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov