Improving PTSD Treatment with AWARE, CPT, and PE
This study is looking at ways to make treatments for post-traumatic stress disorder (PTSD) even better. Researchers are testing an intervention called "Adjunctive Writing to Amplify Response and Engagement" (AWARE). AWARE involves you writing about your treatment experiences, and your therapist using these writings to guide discussions. This is being studied alongside two established PTSD therapies: Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE). The goal is to see if AWARE improves how well patients and therapists communicate, and ultimately, if it leads to better PTSD outcomes. You might be able to join if you have PTSD, are at least 18 years old, and are stable on any psychiatric medications. The study aims to enroll 54 participants. Success will be measured by improvements in patient-therapist communication and PTSD symptoms right after treatment and three months later. The current status of this study is unclear.
- Study design
- This interventional study plans to enroll 54 participants. It is testing different behavioral therapies for PTSD.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for three months after your treatment ends to check on your PTSD symptoms.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Elizabeth Alpert, PhD · PRINCIPAL_INVESTIGATOR · National Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Patient-provider communication: VR-CoDES (Posttreatment)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)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)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 adherenceImmediately 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 competenceImmediately 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 adherenceImmediately 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 competenceImmediately 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)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)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)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)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 CompletionImmediately after ending treatment
Proportion of patients who completed a full course of the assigned treatment