NCT06088303 · Boston University
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
(AWARE)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
Adjunctive writing to amplify response and engagement (AWARE)
AWARE includes two components: 1) patients complete brief writing prompts asking about their experiences in treatment, and 2) therapists review patients' responses and facilitate guided discussion related to patients' experiences during check-ins at the beginning of each session.
BEHAVIORAL
Cognitive processing therapy (CPT)
CPT is a manualized, evidence-based therapy for PTSD typically delivered over the course of 8-15 weekly 60-minute sessions. CPT focuses on helping patients identify trauma-related stuck points (inaccurate and/or unhelpful beliefs) and challenge those beliefs to arrive at healthier, more balanced beliefs about their traumatic experiences, themselves, others, and the world.
BEHAVIORAL
Prolonged exposure (PE)
PE is a manualized, evidence-based therapy for PTSD typically delivered over the course of 8-15 weekly 90-minute sessions. PE focuses on reducing unhelpful avoidance and helping patients process and make sense of their traumatic experiences through in vivo and imaginal exposure to trauma-related reminders and memories.
Primary outcome measures
Patient-provider communication: VR-CoDES (Posttreatment)
Time frame: Immediately after ending treatment
Verona Coding Definitions of Emotional Sequences (VR-CoDES) - Observational Coding - Used to code patient writing and recordings of each weekly session check-in for 1) patient disclosure of concerns and 2) therapists' responses to patients' concerns. A random selection of 25% of session recordings will be rated. Patients' cues and concerns and providers' responses to patients' cues and concerns are classified into 25 categories, coded as present/absent. Codes will be averaged across all treatment sessions coded.
PTSD: CAPS-5 (Posttreatment)
Time frame: Immediately after ending treatment
Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5) - Clinician Interview - The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
PTSD: CAPS-5 (Follow-up)
Time frame: 3 months after ending treatment
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) - Clinician Interview - The CAPS-5 includes 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Feasibility assessed by CPT adherence
Time frame: Immediately after ending treatment
CPT Therapist Adherence and Competence Protocol-Revised - Observer Rating - CPT adherence is the percentage of CPT protocol elements completed across therapy sessions, rated from 0-100%, with a higher percentage indicating greater adherence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. Completion of ≥ 90% mean adherence to protocol elements indicates high CPT adherence, and would be an indicator of feasibility of AWARE.
Feasibility assessed by CPT competence
Time frame: Immediately after ending treatment
CPT Therapist Adherence and Competence Protocol-Revised - Observer Rating - CPT competence is the skill with which therapists implement CPT protocol elements across therapy sessions, rated from 1-7, with higher scores indicating greater competence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. A score of good (5) or greater on the 1-7 scale indicates high CPT competence, and would be an indicator of feasibility of AWARE.
Feasibility assessed by PE adherence
Time frame: Immediately after ending treatment
PE Fidelity Rating Form - Observer Rating - PE adherence is the percentage of PE protocol elements completed across therapy sessions, rated from 0-100%, with a higher percentage indicating greater adherence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. Completion of ≥ 90% mean adherence to protocol elements indicates high PE adherence, and would be an indicator of feasibility of AWARE.
Feasibility assessed by PE competence
Time frame: Immediately after ending treatment
PE Fidelity Rating Form - Observer Rating - PE competence is the skill with which therapists implement PE protocol elements across therapy sessions, rated from 1-7, with higher scores indicating greater competence. A random selection of 50% of session recordings will be rated, and ratings will be averaged across all rated sessions. A score of good (5) or greater on the 1-7 scale indicates high PE competence, and would be an indicator of feasibility of AWARE.
Acceptability: Client satisfaction (Mid-treatment)
Time frame: After 6 sessions
Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability.
Acceptability: Client satisfaction (Posttreatment)
Time frame: Immediately after ending treatment
Client Satisfaction Questionnaire (CSQ) - Self-Report - The CSQ has 8 items assessing client satisfaction with the treatment they have received. Total scores range from 8-32; higher scores indicate greater client satisfaction/treatment acceptability.
Acceptability: Therapeutic Alliance (Mid-treatment)
Time frame: After 6 sessions
Working Alliance Inventory Short-Revised (WAI-SR) - Self-Report - The WAI-SR has 12 items assessing three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and therapeutic bond. Total scores range from 12-60; higher scores indicate stronger therapeutic alliance/treatment acceptability.
Acceptability: Therapeutic Alliance (Posttreatment)
Time frame: Immediately after ending treatment
Working Alliance Inventory Short-Revised (WAI-SR) - Self-Report - The WAI-SR has 12 items assessing three aspects of the therapeutic alliance: agreement on tasks, agreement on goals, and therapeutic bond. Total scores range from 12-60; higher scores indicate stronger therapeutic alliance/treatment acceptability.
Treatment Completion
Time frame: Immediately after ending treatment
Proportion of patients who completed a full course of the assigned treatment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Boston, Massachusetts
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations