[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613147":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":34,"locations":42,"responsibleParty":68,"collaborators":11,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":11,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":11,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"4-week mindfulness intervention","EXPERIMENTAL",null,[13],"Behavioral: 4-week mindfulness-based intervention",{"label":15,"type":16,"description":11,"interventionNames":11},"Waitlist treatment as usual control","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"BEHAVIORAL","4-week mindfulness-based intervention","This is the first mindfulness-based intervention specifically designed for postpartum mothers and birthing parents with clinical anxiety. The protocol is adapted from Mindfulness-Based Cognitive Therapy for Depression (by J. Mark G. Williams, John D. Teasdale, and Zindel Segal), and is explicitly tailored to address anxiety disorders during the postpartum period. Most existing mindfulness-based protocols primarily target anxiety during pregnancy, are suitable for both clinical and subclinical levels of anxiety, and are commonly applied to both postpartum depression and anxiety populations.",[9],[24,27,30],{"name":25,"affiliation":5,"role":26},"Sheryl M Green, Ph.D., C.Psych","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":5,"role":29},"Benicio N Frey, MD, PhD, FRCPC","STUDY_CHAIR",{"name":31,"affiliation":32,"role":33},"Zoryana Babiy, M.Sc.","McMaster University","STUDY_DIRECTOR",[35,40],{"name":25,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","905-522-1155","33672","sgreen@stjosham.on.ca",{"name":31,"role":36,"phone":11,"phoneExt":11,"email":41},"babiyz@mcmaster.ca",[43,60],{"facility":44,"status":45,"city":46,"state":47,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton","RECRUITING","Hamilton","Ontario","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-79.84963,43.25011,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":37,"phoneExt":38,"email":59},"Sheryl M Green","sgreen@stjoes.ca",{"facility":61,"status":45,"city":46,"state":47,"zip":11,"country":48,"countryCode":49,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Women's Health Concerns, St. Joseph's Healthcare Hamilton",{"type":51,"coordinates":63},[53,54],{"lat":54,"lon":53},[66],{"name":67,"role":36,"phone":37,"phoneExt":38,"email":59},"Sheryl Green, PhD, C.Psych",{"type":26,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Sheryl Green","Dr. Sheryl Green, Ph.D., C.Psych","100613147","psychological-and-physiological-impact-of-a-mindfulness-based-intervention-on-anxiety-disorders-during-the-postpartum-period-100613147",false,"NCT07262801","Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period","Evaluating the Psychological and Physiological Impact of a Mindfulness-based Intervention on Anxiety Disorders During the Postpartum Period: A Proof of Concept Trial","Inclusion Criteria:\n\n* mothers\u002Fbirthing parents 18 years and older who are between 0-12 months postpartum\n* principal diagnosis of an anxiety disorder as per the Diagnostic Assessment Research Tool (DART; Schneider et al., 2022), with or without comorbid depression\n* no concurrent psychological treatment\n* not taking psychoactive medication or a) medications are stable in dose and type for at least 8 weeks prior to the study (as per Canadian psychiatric guidelines; McQueen et al., 2016) and b) medications remain stable throughout the study\n* fluent in English, minimal grade 8 reading level.\n\nExclusion Criteria:\n\n* severe depression\u002Fsuicidality requiring acute intervention\n* women with psychotic or current alcohol or substance use disorders\n* suffering from severe claustrophobia\n* metallic objects in body (metal implants, pacemakers)\n* currently pregnant","FEMALE","18 Years",{"count":81,"type":82},50,"ESTIMATED","INTERVENTIONAL",[85],"NA","Postpartum anxiety (PPA) affects up to 20% of mothers in the first year after delivery, with mothers often reporting both psychological and physical symptoms. Present non-pharmacological interventions are effective at improving some psychological aspects of PPA such as anxiety, depressive mood, and distress. However, current interventions are not effective in improving emotion regulation (ER), something that many with PPA experience impairment in. Current interventions also seldom target the physical aspects of anxiety, such as bodily awareness - sensing and understanding internal signals in the body (e.g., sensing a fast heartbeat). There is a link between ER and bodily awareness, however psychological interventions that target both these aspects have not been investigated in the PPA population. As a result, a mind-body intervention targeting both ER and bodily awareness is needed to offer a more holistic treatment option.\n\nThe purpose of the proposed study is to test the effectiveness of a 4-week mindfulness intervention on anxiety symptoms, ER, and bodily awareness in those with PPA. We will use self-report questionnaires alongside brain imaging (functional magnetic resonance imaging; fMRI) to evaluate the effectiveness. Combining both subjective and objective measures will provide greater confidence in our findings, ensuring a more comprehensive understanding of the intervention's impact. Self-report questionnaires will be administered at enrolment, immediately post-intervention, and 4 weeks post-intervention. Brain imaging will be conducted at enrolment and immediately post-intervention. We believe this intervention will lead to improvements in anxiety symptoms, ER, and bodily awareness on the questionnaires and fMRI scans.\n\nIf effective, the proposed mindfulness intervention will target a broader range of psychological and physical symptoms, and reduce the negative impact of PPA on mothers and their infants in Canada and beyond.",[88,89],"Postpartum Anxiety","Anxiety Disorders",[91,92,93,94,95,96,97,98,99],"postpartum anxiety","anxiety disorders","mothers","mindfulness","mindfulness-based intervention","emotion regulation","interoception","fMRI","resting state functional connectivity","2025-12-01",{"date":102,"type":103},"2025-12-04","ACTUAL",{"date":105,"type":82},"2025-12",{"date":107,"type":82},"2026-09",{"name":5,"class":6},2]