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Behavioural Intervention

Enhanced PTSD Communication Strategies for Post-Traumatic Stress Disorder (AWARE Trial)

N/A

Waitlist Available

Led By Elizabeth Alpert, PhD

Research Sponsored by Boston University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PTSD

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after ending treatment

Awards & highlights

AWARE Trial Summary

This trial studies whether existing PTSD treatments can be improved by adding a writing task and guided responses to enhance patient-therapist communication. 4 participants will get the new approach, and 50 more will be randomly assigned to get the new or usual treatments.

Who is the study for?

This trial is for adults with PTSD who are stable on psychiatric medications for at least a month. It's not suitable for individuals with unstable bipolar disorder, psychosis, severe substance use needing immediate attention, active suicidal or homicidal thoughts, those already in trauma-focused treatment, or with cognitive impairments like advanced dementia.Check my eligibility

What is being tested?

The study tests if an adjunctive writing intervention called AWARE can improve outcomes of two existing PTSD treatments: Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE). Participants will either receive standard CPT/PE or the same therapies supplemented with AWARE to enhance patient-therapist communication.See study design

What are the potential side effects?

While the trial itself does not involve medication side effects, engaging in PTSD therapy such as CPT and PE may lead to temporary increases in distress due to discussing traumatic events. The impact of adding AWARE on these experiences is part of what the study aims to assess.

AWARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD.

AWARE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after ending treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after ending treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after ending treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability: Client satisfaction (Mid-treatment)

Acceptability: Client satisfaction (Posttreatment)

Acceptability: Therapeutic Alliance (Mid-treatment)

+9 more

Secondary outcome measures

Depression (Follow-Up)

Depression (Posttreatment)

Functional impairment (Follow-up)

+4 more

AWARE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CPT/PE with AWAREExperimental Treatment3 Interventions

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.

Group II: CPT/PE TAUActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Prolonged exposure (PE)

2011

Completed Phase 3

~150

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor

454 Previous Clinical Trials

9,941,516 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,784 Previous Clinical Trials

2,689,221 Total Patients Enrolled

Elizabeth Alpert, PhDPrincipal InvestigatorNational Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for enrolment in this scientific experiment?

"According to clinicaltrials.gov, this medical trial is no longer recruiting patients, having last been updated on October 12th of 2023. Despite the conclusion of patient recruitment for this particular study, 331 other trails are currently seeking participants."

Answered by AI

What is the goal of this medical experiment?

"This clinical trial's primary outcome, to be monitored shortly after the conclusion of treatment, is PTSD: CAPS-5 (Posttreatment). Secondary outcomes measure the severity of posttraumatic stress disorder and depression with tests such as the PCL-5 - Self Report and PHQ-9."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication

2024. "Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088303.

All > Post Traumatic Stress Disorder > Ptsd