[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06096740":3,"trial-entities:NCT06096740":115,"trial-summary:NCT06096740":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":31,"primary_purpose":32,"phases":33,"enrollment_info":35,"interventions":38,"primary_outcomes":46,"secondary_outcomes":51,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":84,"locations":87,"central_contacts":106,"overall_officials":109,"references":113,"see_also_links":114},"NCT06096740","STUDY00004746","Psychotherapy Effects on Reward Processing in PTSD","The Effects of Trauma-focused Psychotherapy on Reward Circuitry Function and Information Encoding","RECRUITING","2029-05-01","2025-09","2026-05-01","2024-06-01","University of Texas at Austin","OTHER",true,"The purpose of this study is to identify how trauma-focused psychotherapy changes the function of brain circuitry in posttraumatic stress disorder (PTSD) and how this mediates improvements in the diminished ability to experience positive emotions following a traumatic or extremely stressful life event. In this instance, the investigators will be using cognitive processing therapy (CPT), a widely-utilized and evidence-based treatment for PTSD.","The goals of the study are as follows:\n\n1. Quantify, under conditions of safety (no threat), how PTSD psychotherapy alters reward circuit function and information encoding.\n2. Identify how presence of threat augments PTSD psychotherapy effects on reward circuit function and information encoding.\n3. (Exploratory). Identify how, following psychotherapy, changes in reward circuit function and information encoding under conditions of safety and threat are associated with improvements in symptoms of diminished positive affect (DimPA).\n\nTo accomplish the goals of the study, the investigators propose a neuroimaging-coupled, randomized clinical trial of immediate vs. delayed individual cognitive processing therapy (CPT) in individuals (N=120) with a primary diagnosis of chronic PTSD. Individuals will undergo, prior to randomization, clinical and neurobiological assessment with functional magnetic resonance imaging (fMRI) during completion of several reward processing paradigms. Two of these involve both a normal \"safe\" context and a threat context manipulation (threat of mild electrodermal shock that is periodically cycled throughout the task). Another paradigm involves making decisions to either approach reward or forego a reward when this decision conflicts with the likelihood of an aversive outcome. This is known as approach-avoidance conflict (AAC). This battery will provide a comprehensive characterization of reward processing behavior and circuit function and establish its relationship to treatment processes, as well as how such processes may vary as a function of threat.",[19,20,21,22,23,24],"Post Traumatic Stress Disorder","Diminished Pleasure","Anhedonia","PTSD","Chronic PTSD","Chronic Post-Traumatic Stress Disorder",[22,26,27,28,29,30,23],"Post Traumatic Stress","Emotional Numbing","CPT","Cognitive Processing Therapy","Therapy","INTERVENTIONAL","TREATMENT",[34],"NA",{"count":36,"type":37},120,"ESTIMATED",[39],{"type":40,"name":29,"description":41,"armGroupLabels":42,"otherNames":45},"BEHAVIORAL","Cognitive processing therapy is a widely-utilized, empirically-supported treatment developed for PTSD. It is based on a cognitive theory of trauma which emphasizes the impact of trauma on belief systems and the development of \"stuck points\", which are unhealthy, unrealistic, and maladaptive ways of thinking that serve to maintain unhealthy beliefs and reinforce PTSD symptoms.",[43,44],"Delayed Treatment","Immediate Treatment",[28],[47],{"measure":48,"description":49,"timeFrame":50},"Within subject beta coefficients for each parametrically modulated regressor of the Reinforcement Learning Task with Threat","The changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation associated with individual trial-by-trial reinforcement learning computational model parameters at the time of choice valuation (expected reward value during safe contexts and expected reward value during threat contexts) and choice outcome (reward prediction errors during safe contexts and reward prediction errors during threat contexts).","[10 weeks]",[52,55,58],{"measure":53,"description":54,"timeFrame":50},"Within-subject BOLD contrast for unexpected absence of juice vs. expected absence of juice (negative temporal Prediction Errors) for safe and threat contexts.","The changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation between the unexpected absence of juice vs. expected absence of juice in safe contexts and threat contexts.",{"measure":56,"description":57,"timeFrame":50},"Within-subject BOLD contrast for the unexpected delivery of juice vs. the expected delivery of juice (positive temporal Prediction Errors) for safe and threat contexts.","The changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation between the unexpected delivery of juice vs. the expected delivery of juice in both safe and threat contexts.",{"measure":59,"description":60,"timeFrame":50},"Within subject beta coefficients for each parametrically modulated regressor of an approach avoidance conflict task.","The changes in deoxyhemoglobin driven by localized changes in brain blood flow and blood oxygenation associated with individual trial-by-trial reinforcement learning computational model parameters at the time of choice valuation (expected reward value, expected threat value, and conflict between reward and threat value), anticipation (expected reward and threat value), and choice outcome (reward and threat prediction errors).","ALL","18 Years","65 Years",false,{"inclusion":66,"exclusion":71,"raw_text":83},[67,68,69,70],"English as primary language, and comprehension suitable to understand experimenter instructions.","Current and chronic syndromic PTSD, defined as being exposed to a DSM-5 Criterion A traumatic event, with the presence DSM-5 qualifying PTSD symptoms for at least 3 months, as assessed by the Clinician-Administered PTSD Scale for DSM-5.","Able and willing to undergo functional magnetic resonance imaging (fMRI).","Willingness to participate in repeated assessments and as part of a delayed treatment group.",[72,73,74,75,76,77,78,79,80,81,82],"Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview.","Active substance dependence within the past 6 months as evidenced by clinical interview.","Current regular psychiatric medication use (i.e. antidepressants), except for as-needed benzodiazepine or opiate medication no more than three times per week, on average, or for short-duration stimulant medication for attention deficit hyperactivity disorder that can be skipped within 24 hours of study visits.","A recent (\\\u003C6 months) suicide attempt or current active ideation with intent.","Unremovable ferrous metal in body.","History of neurological disorder, stroke, seizures\u002Fconvulsions (except febrile seizures in childhood), epilepsy, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, or thyroid disorder.","Anyone who is pregnant or trying to become pregnant.","Current or past year (\\> 3 sessions), psychotherapy with a prominent exposure or cognitive restructuring component.","Previous or current (es)ketamine treatment and\u002F or brain stimulation\u002Fneuromodulation treatment.","Other ongoing treatment that is likely to confound experimental effects.","Previous penetrating head injury\u002Ftraumatic brain injury. Mild-to-moderate traumatic brain injury without penetrating injury is allowable.","Inclusion Criteria:\n\n* English as primary language, and comprehension suitable to understand experimenter instructions.\n* Current and chronic syndromic PTSD, defined as being exposed to a DSM-5 Criterion A traumatic event, with the presence DSM-5 qualifying PTSD symptoms for at least 3 months, as assessed by the Clinician-Administered PTSD Scale for DSM-5.\n* Able and willing to undergo functional magnetic resonance imaging (fMRI).\n* Willingness to participate in repeated assessments and as part of a delayed treatment group.\n\nExclusion Criteria:\n\n* Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview.\n* Active substance dependence within the past 6 months as evidenced by clinical interview.\n* Current regular psychiatric medication use (i.e. antidepressants), except for as-needed benzodiazepine or opiate medication no more than three times per week, on average, or for short-duration stimulant medication for attention deficit hyperactivity disorder that can be skipped within 24 hours of study visits.\n* A recent (\\\u003C6 months) suicide attempt or current active ideation with intent.\n* Unremovable ferrous metal in body.\n* History of neurological disorder, stroke, seizures\u002Fconvulsions (except febrile seizures in childhood), epilepsy, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, or thyroid disorder.\n* Anyone who is pregnant or trying to become pregnant.\n* Current or past year (\\> 3 sessions), psychotherapy with a prominent exposure or cognitive restructuring component.\n* Previous or current (es)ketamine treatment and\u002F or brain stimulation\u002Fneuromodulation treatment.\n* Other ongoing treatment that is likely to confound experimental effects.\n* Previous penetrating head injury\u002Ftraumatic brain injury. Mild-to-moderate traumatic brain injury without penetrating injury is allowable.",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"status":8,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":103},"Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600","Austin","Texas","78712","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Lauren Enten, B.S.A.","CONTACT","512-495-5856","fonzolab@austin.utexas.edu",{"name":101,"role":102},"Greg Fonzo, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},30.26715,-97.74306,[107],{"name":108,"role":97,"phone":98,"email":99},"Lauren Enten, B.S.A",[110],{"name":111,"affiliation":112,"role":102},"Gregory A Fonzo, PhD","The University of Texas at Austin",[],[],{"nct_id":4,"conditions":116,"biomarkers":118},[117],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":15,"summary":120,"prompt_version":129},{"design":121,"status":122,"heading":6,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study that plans to enroll 120 participants. It is a randomized clinical trial comparing immediate versus delayed Cognitive Processing Therapy.","completed","This study is looking at how a type of talk therapy called Cognitive Processing Therapy (CPT) affects the brain in people with Post Traumatic Stress Disorder (PTSD). Specifically, it wants to understand how CPT changes the brain's ability to experience positive emotions, which can be diminished after a traumatic event. Researchers will compare people who receive CPT right away with those who receive it later. You might be able to join if you are between 18 and 65 years old, speak English, and have chronic PTSD for at least 3 months. The study will measure changes in your brain's reward system after 10 weeks of treatment to see if CPT helps improve your ability to feel pleasure.","The primary endpoint is measured at 10 weeks, indicating follow-up for at least this duration.",117,"Before treatment, you will have clinical and brain imaging (fMRI) assessments while completing tasks related to reward processing. Some tasks involve mild electrical shock or making decisions about rewards versus negative outcomes.","Not stated in the trial record.",[29],"v2"]