Stress Disorders, Post-TraumaticAWARENCT06088303
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
A study testing Adjunctive writing to amplify response and engagement (AWARE), Cognitive processing therapy (CPT) and Prolonged exposure (PE) in people with Stress Disorders, Post-Traumatic, run by Boston University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Adjunctive writing to amplify response and engagement (AWARE), Cognitive processing therapy (CPT) and Prolonged exposure (PE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PTSD
- Stable on psychiatric medications for at least 4 weeks
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Center for PTSD at VA Boston Healthcare System
Boston, Massachusetts, 02130
Elizabeth Alpert, PhD, elizabeth.alpert@va.gov
About this study
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
- Stress Disorders, Post-Traumatic
- Being tested
- Adjunctive writing to amplify response and engagement (AWARE), Cognitive processing therapy (CPT), Prolonged exposure (PE)
- Keywords
- Posttraumatic stress disorder, Cognitive processing therapy, Prolonged exposure, Adjunctive writing for amplifying response and engagement, Health communication, Patient-provider communication
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive writing to amplify response and engagement (AWARE)Behavioural
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.
Cognitive processing therapy (CPT)Behavioural
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.
Prolonged exposure (PE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CPT/PE with AWARE | Experimental | Participants randomized into this arm will receive either cognitive processing therapy (CPT) or prolonged exposure (PE) with the adjunctive writing intervention to amplify response and engagement (AWARE).
CPT and PE are both recommended as gold standard treatments by published PTSD clinical practice guidelines. Participants will choose whether to receive CPT or PE. The standard treatment length will be 8-15 weekly sessions; however, participants and providers may collaboratively agree to early completion or additional sessions as warranted. AWARE will be integrated into the CPT/PE sessions. Receives: Behavioral: Adjunctive writing to amplify response and engagement (AWARE); Behavioral: Cognitive processing therapy (CPT); Behavioral: Prolonged exposure (PE) |
| CPT/PE TAU | Active comparator | Participants randomized into this arm will receive either cognitive processing therapy (CPT) or prolonged exposure (PE) treatment as usual (TAU).
CPT and PE are both recommended as gold standard treatments by published PTSD clinical practice guidelines. Participants will choose whether to receive CPT or PE. The standard treatment length will be 8-15 weekly sessions; however, participants and providers may collaboratively agree to early completion or additional sessions as warranted. Receives: Behavioral: Cognitive processing therapy (CPT); Behavioral: Prolonged exposure (PE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-provider communication: VR-CoDES (Posttreatment)
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.
Measured: Immediately after ending treatment
PTSD: CAPS-5 (Posttreatment)
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.
Measured: Immediately after ending treatment
PTSD: CAPS-5 (Follow-up)
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.
Measured: 3 months after ending treatment
Feasibility assessed by CPT adherence
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.
Measured: Immediately after ending treatment
Feasibility assessed by CPT competence
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.
Measured: Immediately after ending treatment
Feasibility assessed by PE adherence
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.
Measured: Immediately after ending treatment
Feasibility assessed by PE competence
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.
Measured: Immediately after ending treatment
Acceptability: Client satisfaction (Mid-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.
Measured: After 6 sessions
Acceptability: Client satisfaction (Posttreatment)
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.
Measured: Immediately after ending treatment
Acceptability: Therapeutic Alliance (Mid-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.
Measured: After 6 sessions
Acceptability: Therapeutic Alliance (Posttreatment)
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.
Measured: Immediately after ending treatment
Treatment Completion
Proportion of patients who completed a full course of the assigned treatment
Measured: Immediately after ending treatment
Secondary outcomes (7)
Patient-provider communication: PPIS (Posttreatment)
Patient-Provider Interaction Scale (PPIS) - Self-Report - The PPIS has 6 items assessing patients' perceptions of patient-provider communication. The PPIS will be collected every session by study staff, and scores will be averaged across sessions. Total scores range from 6-24; higher scores indicate better patient-provider communication.
Measured: Immediately after ending treatment
PTSD: PCL-5 (Posttreatment)
PTSD Checklist for DSM-5 (PCL-5) - Self-Report - The PCL-5 has 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Measured: Immediately after ending treatment
PTSD: PCL-5 (Follow-up)
PTSD Checklist for DSM-5 (PCL-5) - Self-Report - The PCL-5 has 20 items assessing PTSD symptom severity. Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
Measured: 3 months after ending treatment
Depression (Posttreatment)
Patient Health Questionnaire (PHQ-9) - Self-Report - The PHQ-9 has 9 items assessing depression symptoms. Total scores range from 0-27; higher scores indicating greater depression severity.
Measured: Immediately after ending treatment
Depression (Follow-Up)
Patient Health Questionnaire (PHQ-9) - Self-Report - The PHQ-9 has 9 items assessing depression symptoms. Total scores range from 0-27; higher scores indicating greater depression severity.
Measured: 3 months after ending treatment
Functional impairment (Posttreatment)
World Health Organization Disability Assessment Schedule-II (WHODAS-II) - Self-Report - The WHODAS-II has 36 items assessing disability and functional impairment. Total scores range from 0-144; higher scores indicate greater disability/functional impairment.
Measured: Immediately after ending treatment
Functional impairment (Follow-up)
World Health Organization Disability Assessment Schedule-II (WHODAS-II) - Self-Report - The WHODAS-II has 36 items assessing disability and functional impairment. Total scores range from 0-144; higher scores indicate greater disability/functional impairment.
Measured: 3 months after ending treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Jan 2025
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Alpert, PhD, Principal investigator, National Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088303
- Sponsor's protocol ID
- H-44384
- Other IDs
- 1K23MH132815-01A1
- Acronym
- AWARE
- Status last verified
- Mar 2026
- First submitted
- 12 Oct 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified demographic and raw quantitative data will be deposited into the NIMH Data Archive (NDA). All data will be de-identified prior to receipt by the repository. Data will be de-identified pursuant to the HIPAA Privacy Rule, 45 CFR § 164.514(b). A brief study protocol will also be submitted to NDA and will be made freely available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
- ClinicalTrials.gov ID
- NCT06088303
- Acronym / sponsor ID
- AWARE / H-44384
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Posttraumatic stress disorder, Cognitive processing therapy, Prolonged exposure, Adjunctive writing for amplifying response and engagement, Health communication, Patient-provider communication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPT/PE with AWARE | Experimental | Behavioral: Adjunctive writing to amplify response and engagement (AWARE), Behavioral: Cognitive processing therapy (CPT), Behavioral: Prolonged exposure (PE)Participants randomized into this arm will receive either cognitive processing therapy (CPT) or prolonged exposure (PE) with the adjunctive writing intervention to amplify response and engagement (AWARE). CPT and PE are both recommended as gold standard treatments by published PTSD clinical practice guidelines. Participants will choose whether to receive CPT or PE. The standard treatment length will be 8-15 weekly sessions; however, participants and providers may collaboratively agree to early completion or additional sessions as warranted. AWARE will be integrated into the CPT/PE sessions. |
| CPT/PE TAU | Active comparator | Behavioral: Cognitive processing therapy (CPT), Behavioral: Prolonged exposure (PE)Participants randomized into this arm will receive either cognitive processing therapy (CPT) or prolonged exposure (PE) treatment as usual (TAU). CPT and PE are both recommended as gold standard treatments by published PTSD clinical practice guidelines. Participants will choose whether to receive CPT or PE. The standard treatment length will be 8-15 weekly sessions; however, participants and providers may collaboratively agree to early completion or additional sessions as warranted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of PTSD
- Stable on psychiatric medications for at least 4 weeks
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CPT/PE with AWARE |
| 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. | Behavioural | CPT/PE TAU, CPT/PE with AWARE |
| 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. | Behavioural | CPT/PE TAU, CPT/PE with AWARE |
Primary outcome
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
7 secondary outcomes
Patient-provider communication: PPIS (Posttreatment)
Time frame: Immediately after ending treatment
PTSD: PCL-5 (Posttreatment)
Time frame: Immediately after ending treatment
PTSD: PCL-5 (Follow-up)
Time frame: 3 months after ending treatment
Depression (Posttreatment)
Time frame: Immediately after ending treatment
Depression (Follow-Up)
Time frame: 3 months after ending treatment
Functional impairment (Posttreatment)
Time frame: Immediately after ending treatment
Functional impairment (Follow-up)
Time frame: 3 months after ending treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified demographic and raw quantitative data will be deposited into the NIMH Data Archive (NDA). All data will be de-identified prior to receipt by the repository. Data will be de-identified pursuant to the HIPAA Privacy Rule, 45 CFR § 164.514(b). A brief study protocol will also be submitted to NDA and will be made freely available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth Alpert, PhD principal investigator
National Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjunctive writing to amplify response and engagement (AWARE), Cognitive processing therapy (CPT) and Prolonged exposure (PE) in people with Stress Disorders, Post-Traumatic, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Alpert, PhD (857-364-6190, elizabeth.alpert@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-provider communication: VR-CoDES (Posttreatment) (time frame: Immediately after ending treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.