Enhancing PTSD Treatment Outcomes by Improving Patient-Provider

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06088303
Study type	Interventional
Source	Boston University
Contact	Elizabeth Alpert, PhD
Phone	857-364-6190
Email	elizabeth.alpert@va.gov
Status	Not yet recruiting
Phase	N/A
Start date	September 2024
Completion date	December 2028

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05620381` - Health and Sleep Assessment After the Strasbourg Attacks of December 11, 2018
Completed	`NCT02856412` - Improving Mind/Body Health and Functioning With Integrative Exercise	N/A
Recruiting	`NCT05400200` - PTSD and Self-regulation: Coping, Emotional Regulation and Cognitive Control and Their Relationships to Symptom Management	N/A
Not yet recruiting	`NCT03652922` - Propranolol Reactivation Mismatch (PRM) Treatment for PTSD	Phase 4
Completed	`NCT02875912` - Prospective Evaluation of Family Care Rituals in the ICU	N/A
Completed	`NCT01589575` - Anxiety and Depression in Relatives of Critically Ill Patients: Spouses Versus Other Close Relatives	N/A
Completed	`NCT00990106` - Augmentation Trial of Prazosin for Post-Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT01291368` - Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care	N/A
Active, not recruiting	`NCT00657787` - Development of a Post-Traumatic Stress Disorder (PTSD) Population Registry for Veterans
Completed	`NCT00880152` - Mindfulness Based Stress Reduction for Posttraumatic Stress Disorder: A Pilot Study	N/A
Completed	`NCT01365247` - Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT00835627` - Treatment Trial for Psychogenic Nonepileptic Seizures	Phase 4
Completed	`NCT00419029` - Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment	N/A
Completed	`NCT00514956` - Effect of Emotional Freedom Technique and Diaphragmatic Breathing on Post Traumatic Stress Disorder (PTSD)	Phase 1
Completed	`NCT00333710` - Evaluating a Telehealth Treatment for Veterans With Hepatitis C and PTSD	N/A
Completed	`NCT01120847` - Post Traumatic Stress Disorder (PTSD), Sleep Disordered Breathing And Genetics: Effects On Cognition
Completed	`NCT00069225` - Brain Structure and Function Before and After Treatment for Post-Traumatic Stress Disorder	N/A
Completed	`NCT00055354` - Acupuncture for the Treatment of Post-Traumatic Stress Disorder (PTSD)	N/A
Completed	`NCT00186212` - Alternative Support for Rural and Isolated Women in an HMO	Phase 3
Completed	`NCT00000383` - Treatment of Post-Traumatic Stress Disorder (PTSD) in Sexually Abused Children	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Enhancing PTSD Treatment Outcomes by Improving Patient-Provider Communication — AWARE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms