Clinical trial NCT06088303: Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Official title: Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-10-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Patient-provider communication: VR-CoDES (Posttreatment)
timeFrame: Immediately after ending treatment
measure: PTSD: CAPS-5 (Posttreatment)
timeFrame: Immediately after ending treatment
measure: PTSD: CAPS-5 (Follow-up)
timeFrame: 3 months after ending treatment
measure: Feasibility assessed by CPT adherence
timeFrame: Immediately after ending treatment
measure: Feasibility assessed by CPT competence
timeFrame: Immediately after ending treatment
measure: Feasibility assessed by PE adherence
timeFrame: Immediately after ending treatment
measure: Feasibility assessed by PE competence
timeFrame: Immediately after ending treatment
measure: Acceptability: Client satisfaction (Mid-treatment)
timeFrame: After 6 sessions
measure: Acceptability: Client satisfaction (Posttreatment)
timeFrame: Immediately after ending treatment
measure: Acceptability: Therapeutic Alliance (Mid-treatment)
timeFrame: After 6 sessions
measure: Acceptability: Therapeutic Alliance (Posttreatment)
timeFrame: Immediately after ending treatment
measure: Treatment Completion
timeFrame: Immediately after ending treatment
Secondary outcomes:
measure: Patient-provider communication: PPIS (Posttreatment)
timeFrame: Immediately after ending treatment
measure: PTSD: PCL-5 (Posttreatment)
timeFrame: Immediately after ending treatment
measure: PTSD: PCL-5 (Follow-up)
timeFrame: 3 months after ending treatment
measure: Depression (Posttreatment)
timeFrame: Immediately after ending treatment
measure: Depression (Follow-Up)
timeFrame: 3 months after ending treatment
measure: Functional impairment (Posttreatment)
timeFrame: Immediately after ending treatment
measure: Functional impairment (Follow-up)
timeFrame: 3 months after ending treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: National Center for PTSD at VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: National Center for PTSD at VA Boston Healthcare System, BU School of Medicine, Psychiatry
name: Elizabeth Alpert, PhD
role: PRINCIPAL_INVESTIGATOR
References: