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VA/DOD guidance supports trauma-focused psychotherapy, yet effectiveness is constrained by reduced patient engagement. Cognitive Processing Therapy (CPT) is widely used in Veterans. The pilot protocol evaluates whether adding quetiapine can improve feasibility, safety, and preliminary efficacy of completing CPT by enhancing engagement, compared with placebo. 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Design and methodology of a pilot study  \nMuhammad R Baig1,2,3 *; Jennifer L Wilson1,2; Robert D Beck1,2; Jennifer A Lemmer1,2; Adeel Meraj1; Anna Hernandez1; Eric C Meyer4; Jim Mintz3,5; Alan L Peterson1,3,6; John D Roache3,7  \n1Mental Health, South Texas Veterans Healthcare System, San Antonio, TX, 78229, USA.  \n2Polytrauma Rehabilitation Center, South Texas Veterans Healthcare System, San Antonio, TX, USA.  \n3Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.  \n4Department of Rehabilitation Science and Technology, University of Pittsburgh, Pittsburgh, PA, USA.  \n5Department of Epidemiology and Biostatistics, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA. 6Department of Psychology, University of Texas at San Antonio, San Antonio, TX, USA.  \n7Department of Pharmacology, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.  \n*Corresponding Author: Muhammad Rais Baig  \nMental Health, South Texas Veterans Healthcare System, 116 A, 7400 Merton Minter Blvd, San Antonio, TX, USA.  \nTel: 210-617-5300 Extension: 18244;  \n[Email: Muhammad.baig@va.gov](Email: Muhammad.baig@va.gov)  \nORCID: 0000-0003-4589-7707  \nReceived: Sep 21, 2022  \nAccepted: Oct 25, 2022  \nPublished: Nov 01, 2022  \n[Archived: www.jcimcr.org](Archived: www.jcimcr.org)  \n[Copyright:](Copyright:) © Baig MR (2022) .  \n[DOI: www.doi.org/10.52768/2766-7820/2130](DOI: www.doi.org/10.52768/2766-7820/2130)  \nAbstract  \nBackground: The limited efficacy of first-line treatment of Posttraumatic Stress Disorder (PTSD) with selective serotonergic reuptake inhibitors commonly leads to the use of multiple medications that still fail to achieve symptomatic remission. VA/DOD guidelines identify trauma-focused psychotherapies as the evidence-based treatment for PTSD, but overall effectiveness is limited by reduced levels of patient engagement. Cognitive Processing Therapy (CPT) is the most widelyused trauma-focused therapy in the VA system for Veterans with PTSD. Our previous results based on a case series suggested that quetiapine mono therapy, but not risperidone or valproate, could increase engagement in CPT, thereby improving clinical outcomes through direct medication effects and indirectly through greater engagement in CPT.  \nMethods & results: We report the study protocol of a pilot study. This randomized, double blind placebo-controlled study was designed to evaluate the feasibility, safety, and preliminary efficacy of completing a randomized trial of quetiapine vs. placebo as an adjunct to promote patient engagement in CPT treatment for PTSD.  \nConclusions: We expect that the success of this ongoing study should provide us with the preliminary data necessary to design a fullscale randomized trial.  \nTrial registration: NCT04280965  \nKeywords: Quetiapine; Cognitive processing therapy; Posttraumatic stress disorder; Veterans.  \nAbbreviations: AEs: Adverse Events; AUDIT: Alcohol Use Disorders Identification Test; CAPS-5: Clinician Administered PTSD Scale for DSM- 5; CPT: Cognitive Processing Therapy; DSM-5: Diagnosis and Statistical Manual of Mental Disorder, Fifth Edition; DUDIT: Drug Use Disorders  \nCitation: Baig MR, Wilson JL, Beck RD, Lemmer JA, Meraj A, et al. Quetiapine augmentation of cognitive processing therapy in veterans with posttraumatic stress disorder. Design and methodology of a pilot study. J Clin Images Med Case Rep. 2022; 3(11): 2130.  \nIdentification Test; ECG: Electrocardiogram; GABA: Gamma-aminobutyric Acid; GAD-7: Generalized Anxiety Disorder-7; ISI: Insomnia Sleep Index; PCL-5: PTSD checklist for DSM-5; PHQ-9: Patient Health Questionnaire-9; PTGI: Post Traumatic G","cbCaiqI9MQ6KEWeQ","https://ap.wps.com/l/cbCaiqI9MQ6KEWeQ","pdf",893895,"English","# Abstract\n## Background\n## Methods & results\n## Conclusions\n## Keywords and abbreviations","[{\"question\":\"Why investigate medication augmentation for CPT in PTSD?\",\"answer\":\"First-line SSRI treatment often shows limited efficacy and does not consistently achieve symptomatic remission. Engagement barriers also reduce the overall effectiveness of trauma-focused psychotherapy such as CPT.\"},{\"question\":\"What is the pilot study design aimed to evaluate?\",\"answer\":\"The randomized, double-blind, placebo-controlled pilot study protocol evaluates feasibility, safety, and preliminary efficacy of completing a trial of quetiapine versus placebo as an adjunct to CPT to promote patient engagement.\"},{\"question\":\"What outcomes are expected to support a larger future trial?\",\"answer\":\"The authors expect that results from the ongoing study will provide preliminary data needed to design a full-scale randomized trial.\"}]","Quetiapine augmentation of cognitive processing therapy in veterans with posttraumatic stress disorder - Design and methodology of a pilot study | PDF",1789985213,23]