Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication (AWARE)

Boston University

Status: Enrolling

Conditions: Stress Disorders, Post-Traumatic

Treatments: Behavioral: Prolonged exposure (PE); Behavioral: Adjunctive writing to amplify response and engagement (AWARE); Behavioral: Cognitive processing therapy (CPT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06088303

1K23MH132815-01A1 (U.S. NIH Grant/Contract)

H-44384

Details and patient eligibility

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. 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

CPT/PE with AWARE

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive processing therapy (CPT)

Behavioral: Adjunctive writing to amplify response and engagement (AWARE)

Behavioral: Prolonged exposure (PE)

CPT/PE TAU

Active Comparator group

Description:

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:

Behavioral: Cognitive processing therapy (CPT)

Behavioral: Prolonged exposure (PE)