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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
Must not have
Current unstable bipolar disorder
Significant cognitive impairment that would prevent engagement in assessments and therapy (e.g., advanced dementia, severe traumatic brain injury).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after ending treatment
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My bipolar disorder is currently not stable.
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I do not have severe memory or thinking problems that would stop me from participating in therapy.
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I am currently receiving treatment focused on trauma.

Timeline

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

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

Find a Location

Who is running the clinical trial?

Boston UniversityLead Sponsor
461 Previous Clinical Trials
9,951,641 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,765 Total Patients Enrolled
Elizabeth Alpert, PhDPrincipal InvestigatorNational Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry
~36 spots leftby Oct 2028