[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612231":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":19,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Psychotherapy arm","EXPERIMENTAL","The psychotherapy intervention will be delivered virtually over 12 weeks, 1x\u002Fweek for 1 hour, 1-on-1 with a therapist",[13],"Other: Psychotherapy",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Psychotherapy","Session 1 - Psychoeducation: Introductions + information about adversity and depression\n\nSession 2 - Behavioural Activation: Identify activation targets, create Daily Activities Schedule\n\nSession 3 - Identifying Emotions: Describe + label emotions; cycle of emotions\n\nSession 4 - Distress Tolerance: STOP + TIP skills\n\nSession 5 - Distress Tolerance: Self-soothing + improving the moment\n\nSession 6 - Stuck Points: Stuck points + impact statements\n\nSession 7 - Self-blame Beliefs: Negative self schemas; alternative thoughts worksheet\n\nSession 8 - Safety + Trust: Schemas of emotional safety and trust about self and others\n\nSession 9 - Power + Control: Stuck points related to scope of influence over events + the world\n\nSession 10 - Esteem: Reconstruct ideas of self; engaging positively with others\n\nSession 11 - Intimacy: Develop self- and other intimacy behaviours\n\nSession 12 - Wrap-up: Review new impact statements; revisit behavioural chang",[9],null,[21,24,26],{"name":22,"affiliation":5,"role":23},"Benicio Frey, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":25,"affiliation":5,"role":23},"Sheryl Green, PhD",{"name":27,"affiliation":5,"role":23},"Jenna Boyd, PhD",[29],{"name":30,"role":31,"phone":32,"phoneExt":19,"email":33},"Katerina Dikaios, MSc","CONTACT","9028779750","dikaiosk@mcmaster.ca",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Hamilton","Ontario","L8P 3R2","Canada","CA",{"type":43,"coordinates":44},"Point",[45,46],-79.84963,43.25011,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":32,"phoneExt":19,"email":33},"Katerina Dikaios, MSc.",{"type":23,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Benicio Frey","Professor, Psychiatry & Behavioural Neurosciences; Director, Women's Health Concerns Clinic, St. Joseph's Healthcare Hamilton",[55],{"name":56,"class":6},"Sun Life Financial Movement Disorders Research and Rehabilitation Centre","100612231","resolving-early-life-stress-psychotherapy-outcomes-and-neurobiology-in-complex-depression-100612231",false,"NCT07250893","Resolving Early Life Stress: Psychotherapy Outcomes and Neurobiology in Complex Depression","RESPOND","Inclusion Criteria:\n\n* Adults 18 years old or older\n* At or above 18 on HAM-D, indicative of moderate-severe depressive symptoms\n* Any childhood (before 18 years old) adversity as indicated by scores on the CECA q and ACES q\n\nExclusion Criteria:\n\n* Individuals who meet for PTSD diagnosis from a criterion A trauma occurring in adulthood without a history of ELA\n* Individuals experiencing active mania or psychosis\n* Individuals with an active substance use disorder\n* Individuals presenting with active suicide risk (plan, intention, means) indicative of a need for higher level care\n* Individuals in current psychotherapeutic treatment (defined as having engaged in consistent psychotherapy within the last 3 months)","FEMALE","18 Years","65 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"NA","The RESPOND trial explores the link between early life adversity and later life depressive symptoms. The investigators have designed a new psychological therapy tailored to address the symptoms that can be caused by difficult experiences in early life. These symptoms include low mood, emotional dysregulation, and distressing thoughts and beliefs related to difficult or traumatic experiences. The investigators would like to see if this new therapy helps people feel better. The investigators are also studying the biological changes that can occur as a result of early life adversity, and how this therapy may influence those changes. To do this, the investigators ask questions about participants' physical and mental health and take blood samples.",[75,76],"Depression - Major Depressive Disorder","Childhood Traumas",[78,79,80,81],"Early life adversity","Depression","Emotional dysregulation","Childhood trauma","2026-01-30",{"date":84,"type":85},"2026-02-03","ACTUAL",{"date":87,"type":85},"2025-10-25",{"date":89,"type":69},"2028-08-15",{"name":5,"class":6},1]