[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504845":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Mismatch reactivation condition","EXPERIMENTAL","The participant will recite their trauma narrative to the psychologist for 10-20 minutes. However, during each recitation, a \"mismatch\" condition, different for each session, will be added to the reactivation procedure by having the participant do the following (in order of sessions.",[13,14],"Behavioral: Memory reactivation procedures","Drug: Propranolol",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard reactivation condition","ACTIVE_COMPARATOR","The intervention will be the same for each of the six intervention sessions. The participant will recite to the psychologist the narrative they previously composed for 10-20 min. The psychologist will congratulate the participant for having succeeded in this task and advise them they are finished for the day.",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Memory reactivation procedures","In the Mismatch condition, a different, unexpected mismatch will be incorporated into the reactivation. In the Standard condition, the participant will read the narrative the same way each time.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Propranolol","Propranolol will be administered 60-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions.",[9,16],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"James Cappellucci","CONTACT","857.282.1724","jcappellucci@partners.org",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Massachusetts General Hospital Home Base Program","RECRUITING","Charlestown","Massachusetts","02129","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.062,42.37787,{"lat":51,"lon":50},[54,58],{"name":55,"role":35,"phone":56,"phoneExt":26,"email":57},"Kaloyan Tanev, MD","617-764-6476","ktanev@bwh.harvard.edu",{"name":59,"role":35,"phone":60,"phoneExt":26,"email":61},"Oren Bazer, BA","774-279-7599","obazer@mgh.harvard.edu",{"type":63,"investigatorFullName":55,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Senior Director of Research, The Home Base Program","100504845","phase-4-mismatch-vs-standard-intervention-during-memory-reconsolidation-blockade-with-propranolol-effect-on-psychophysiological-reactivity-during-traumatic-imagery-100504845",false,"NCT05853627","Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on Psychophysiological Reactivity During Traumatic Imagery","Inclusion Criteria:\n\n* Initial participants will be males or females 18-65 years old who have experienced a traumatic event that meets the DSM-5 PTSD A criterion, and whose PCL-5 score is \\>33 (to maximize the likelihood that they will meet our psychophysiological inclusion criterion). In order to be randomized, participants must further meet this psychophysiological inclusion criterion during baseline script-driven imagery testing Although we do not require a diagnosis of PTSD, because we have set a minimum psychophysiological inclusion criterion and a valid Criterion A traumatic event, our sample will include a substantial number, likely a majority, of PTSD participants.\n\nExclusion Criteria:\n\n1. Basal sitting or standing systolic blood pressure \\\u003C90\u002F60 mm Hg or basal HR \\\u003C50 BPM. Those participant-candidates excluded for this reason with such readings will be counseled and referred for further clinical consultation if symptomatic or if they wish to be referred even if asymptomatic.\n2. Medical condition that contraindicates PPNL, e.g., congestive heart failure, heart block, insulin- requiring diabetes, chronic bronchitis, emphysema, or asthma. Asthma attacks will only be exclusionary if they: a) occurred within the past ten years, b) occurred at any time in life if induced by a β-blocker, or c) are currently being treated\n3. Previous adverse reaction to, or non-compliance with, a β-blocker\n4. Current use of medication that may involve potentially dangerous or confounding interactions with PPNL, including anti- hypertensives, antiarrhythmics, and benzodiazepines. (Possible inhibition of CYP2D6 isoenzyme-dependent reactions will not be of concern in this study, because PPNL will only be administered once a week)\n5. Presence of drugs of abuse, including opiates, marijuana, cocaine, amphetamines, or alcohol at the initial assessment\n6. Pregnancy or breast feeding. Women of childbearing potential will have a pregnancy test at the initial assessment\n7. Presence of a contraindicating psychiatric condition, e.g., psychotic, bipolar, melancholic, or active substance use disorder; or suicidality (see below)\n8. Initiation of, or change in, psychotropic medication within the previous two months. For participants receiving stable doses of pharmacotherapy, they and their clinicians-prescribers will be asked not to alter the regimen during the proposed two-month study period (excluding the one-month follow-up) except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis about retaining the participant or terminating participation\n9. Current participation in any psychotherapy other than supportive. Participants will be asked not to initiate new psychotherapy during the proposed two-month study period (excluding the one-month follow-up) except in clinically urgent circumstances. If this becomes necessary, a decision will be made on a case-by-case basis about retaining the participant or terminating participation\n10. Inability to understand the study's procedures, risks, and side effects, or to otherwise give informed consent for participation\n11. Participant candidate does not understand English. This exclusion criterion is necessary because the procedures require a nuanced dialogue with English-speaking investigators.","ALL","18 Years","65 Years",{"count":75,"type":76},80,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various \"amnestic\" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated.\n\nPrior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of \"standard\" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery.\n\nParticipants will be randomized to one of 2 treatment arms: STD\u002FPPNL and MM\u002FPPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM\u002FPPNL group shows lower subsequent physiological responses than the STD\u002FPPNL group",[82],"Stress Disorders, Post-Traumatic","2026-05-05",{"date":85,"type":86},"2026-05-06","ACTUAL",{"date":88,"type":86},"2023-06-15",{"date":90,"type":76},"2026-07-01",{"name":5,"class":6},1]