Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06088303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-10-12
Brief Title:
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Sponsor:
Boston University
Organization:
Boston University
Study Overview
Official Title:
Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AWARE
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 CPTPE as usual or CPTPE with AWARE It is expected that 25 participants will be randomized to CPTPE with AWARE and 25 participants will be randomized to receive CPTPE 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 CPTPE as usual
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23MH132815-01A1 | NIH | None | httpsreporternihgovquickSearch1K23MH132815-01A1 |