[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07733310":3,"trial-entities:NCT07733310":97,"trial-summary:NCT07733310":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":54,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":14,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":90,"overall_officials":94,"references":95,"see_also_links":96},"NCT07733310","20251473","Augmented Depression Therapy (ADepT) Case Series","NOT_YET_RECRUITING","2028-12-31","2026-07","2026-07-29","2026-08-01","Ohio State University","OTHER",false,"This research study plans to examine the use of Augmented Depression Therapy (ADepT) in order to evaluate what patients think about ADepT and how well it works. ADepT is a type of therapy that builds wellbeing and is being provided to you as standard of care.\n\nADepT treatment consists of 15 therapy sessions (typically provided weekly) with each session lasting around 60 minutes. Following these sessions, you can receive five optional booster sessions over the next 12 months with each of these lasting around 60 minutes. Ultimately, the timing and duration of these sessions will be determined between you and your provider and scheduled accordingly.\n\nAs part of this study you will be randomized (randomly assigned) to different research assessment lengths before the start of treatment and then will complete assessments for the 12 months following the end of the weekly portion of ADepT treatment. The length of your participation will be between 70 weeks to 82 weeks.",null,[18],"Depression \u002F Major Depressive Disorder",[20,21,22],"Depression","Major Depressive Disorder","Major Depressive Episode","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},40,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35},"BEHAVIORAL","Augmented Depression Therapy (ADepT)","ADepT is a solution-focused behavioral health intervention that blends techniques from cognitive, behavioral, and acceptance-based treatments to help patients manage symptoms of depression and increase wellbeing. It consists of 15 acute treatment sessions and up to 5 booster sessions.",[36,37,38,39,40,41],"3 week baseline + ADepT","4 week baseline + ADepT","5 week baseline + ADepT","6 week baseline + ADepT","7 week baseline + ADepT","8 week baseline + ADepT",[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Acceptability","Patient ratings of treatment acceptability","From enrollment to the end of treatment at 82 weeks",{"measure":48,"description":49,"timeFrame":50},"Attrition","Patient attendance records","From enrollment to the end of treatment at 82 weeks.",{"measure":52,"description":53,"timeFrame":50},"Adverse Events","Self-reported adverse events",[55,58,61],{"measure":56,"description":57,"timeFrame":50},"Montgomery-Asberg Depression Rating Scale (MADRS)","The MADRS is a clinician-administered, 10-item assessment tool used to measure the severity of depressive symptoms and monitor changes in depression over time. Min=0, Max=60, higher scores indicate worse depression.",{"measure":59,"description":60,"timeFrame":50},"Patient Health Questionnaire - 9 Item Version (PHQ-9)","The PHQ-9 is a 9-item self-report measure of depression severity. Min=0, Max=27, higher scores indicate worse depression.",{"measure":62,"description":63,"timeFrame":50},"Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)","The WEMWBS is a 14-item self-report questionnaire designed to measure positive mental wellbeing, including emotional, psychological, and social functioning. Min=14, Max=70, higher scores indicate higher levels of wellbeing.","ALL","18 Years","65 Years",{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"Inclusion Criteria:\n\n1. Aged 18 -65\n2. Currently experiencing a major depressive episode based on the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID-5; First \\& Williams, 2021)\n3. Scoring \\> 10 on the PHQ-9\n4. Have sufficient knowledge of written and spoken English to provide consent and utilize therapy resources and take assessment measures throughout the protocol without the assistance of a translator.\n\nExclusion Criteria:\n\n1. Diagnosis of a psychotic or bipolar disorder\n2. History of learning disabilities or organic brain change (e.g., from injury or from neurological disorders)\n3. Active alcohol or substance use disorder or level of use that would interfere with ability to engage in ADepT treatment\n4. Current marked risk to self (self-harm or suicidal ideation) that cannot be managed safely within the ADepT treatment frame\n5. Patients cannot be enrolled while they are currently receiving psychotherapy from a different provider in line with current clinic policy and APA ethical guidelines. The possibility of switching providers\u002Ftreatments will be addressed following established departmental policies and procedures, transcranial magnetic stimulation, ketamine, esketamine, or electroconvulsive therapy. Patients receiving a stable dose of an antidepressant agent will be considered eligible.\n6. Presence of another psychiatric disorder judged to be primary",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":87},"The Ohio State University Wexner Medical Center","Columbus","Ohio","43214","United States",[82],{"name":83,"role":84,"phone":85,"email":86},"Jay Fournier, PhD","CONTACT","614-814-6485","jay.fournier@osumc.edu",{"lat":88,"lon":89},39.96118,-82.99879,[91],{"name":92,"role":84,"phone":85,"email":93},"Jay Fournier, Ph.D.","Jay.Fournier@osumc.edu",[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Unipolar Depression",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study planning to enroll 40 participants. It is a case series, meaning it will observe the effects of ADepT on a group of individuals.","completed","ADepT Therapy for Depression","This study is looking at a therapy called Augmented Depression Therapy (ADepT) for people experiencing a major depressive episode. ADepT is a type of behavioral therapy that combines different techniques to help manage depression symptoms and improve well-being. Researchers want to understand what patients think about ADepT and how effective it is. You might be able to join if you are 18-65 years old, have been diagnosed with a major depressive episode, and score above 10 on a depression questionnaire (PHQ-9). The study will measure how acceptable the therapy is, how many people complete it, and any side effects over 82 weeks.","You would be followed from enrollment to the end of treatment, which is 82 weeks.",102,"You would attend 15 therapy sessions, typically weekly and lasting about 60 minutes each. You could also have up to 5 optional booster sessions over the next 12 months, each lasting about 60 minutes.","Not stated in the trial record.",[33],"v2"]