[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658869":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":63,"studyPopulation":52,"armGroups":64,"interventions":80,"overallOfficials":88,"centralContacts":93,"locations":103,"responsibleParty":120,"collaborators":122,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":52,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":152,"whyStopped":52,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Istanbul Nisantasi University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Depression Severity (HAM-D-17)","Depression severity measured with the 17-item Hamilton Depression Rating Scale (Turkish version), administered by an independent assessor blind to group allocation. Total score ranges from 0 to 52; higher scores indicate more severe depression. Change from baseline to week 18 is compared between each active therapy and the waitlist control.","Baseline, week 9, and week 18",[14,17,21,24,27,31,34,37,41,45,49],{"measure":15,"description":16,"timeFrame":12},"Change in Self-Reported Depressive Symptoms (BDI-II)","Measured with the Beck Depression Inventory-II (Turkish version). Total score ranges from 0 to 63; higher scores indicate more severe depressive symptoms.",{"measure":18,"description":19,"timeFrame":20},"Treatment Response Rate","Percentage of participants achieving a reduction of 50% or more in HAM-D-17 total score from baseline.","Week 18",{"measure":22,"description":23,"timeFrame":20},"Remission Rate","Percentage of participants with a HAM-D-17 total score of 7 or less.",{"measure":25,"description":26,"timeFrame":12},"Change in Anxiety Symptoms (BAI)","Measured with the Beck Anxiety Inventory (Turkish version). Total score ranges from 0 to 63; higher scores indicate more severe anxiety.",{"measure":28,"description":29,"timeFrame":30},"Change in Quality of Life (WHOQOL-BREF-TR)","Measured with the Turkish version of the World Health Organization Quality of Life Scale, Brief Form. Physical, psychological, social relationships, and environment domain scores are transformed to a 0-100 scale; higher scores indicate better quality of life.","Baseline and week 18",{"measure":32,"description":33,"timeFrame":12},"Change in Negative Automatic Thoughts (ATQ)","Measured with the Automatic Thoughts Questionnaire (Turkish version), 30 items. Total score ranges from 30 to 150; higher scores indicate more frequent negative automatic thoughts. Examined as a proposed mediator of change in cognitive behavioral therapy.",{"measure":35,"description":36,"timeFrame":12},"Change in Defense Styles (DSQ-40)","Measured with the Defense Style Questionnaire-40 (Turkish version). Mean scores for mature, neurotic, and immature defense styles each range from 1 to 9; higher scores indicate greater use of that defense style. Examined as a proposed mediator of change in brief psychoanalytic therapy.",{"measure":38,"description":39,"timeFrame":40},"Therapeutic Working Alliance (WAI)","Measured in the two active therapy arms with the short form of the Working Alliance Inventory (Turkish version), administered after therapy sessions 3 and 12. Covers goal, task, and bond dimensions. Total score ranges from 12 to 84; higher scores indicate a stronger therapeutic alliance.","Week 3 and week 12",{"measure":42,"description":43,"timeFrame":44},"Maintenance of Treatment Effects at Follow-Up","Depression severity (HAM-D-17, range 0-52; BDI-II, range 0-63; higher scores indicate greater severity) in the brief psychoanalytic therapy and cognitive behavioral therapy arms, compared with post-treatment scores to assess durability of change.","6 months and 12 months after the end of treatment (approximately week 44 and week 70 from baseline)",{"measure":46,"description":47,"timeFrame":48},"Treatment Dropout and Session Attendance","Percentage of participants discontinuing treatment before session 12, and mean number of sessions attended per arm.","Up to 20 weeks",{"measure":50,"description":51,"timeFrame":48},"Number of Participants With Adverse Events or Clinical Deterioration","Number of participants with adverse events, clinically significant deterioration (increase of 25% or more in HAM-D-17 from baseline), or emergent suicide risk (HAM-D item 3 score of 3 or higher) requiring referral.",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":52,"timePerspective":52,"maskingInfo":58},"RANDOMIZED","PARALLEL","Three-arm, parallel-group randomized controlled trial. Participants are randomized 1:1:1 to brief psychoanalytic therapy, cognitive behavioral therapy, or waitlist plus treatment as usual, using permuted blocks of 3 and 6 stratified by antidepressant use and baseline HAM-D-17 severity. After the week-18 assessment, waitlist participants are offered one of the active therapies; their post-waitlist data are not included in the primary comparisons.","TREATMENT",{"masking":59,"maskingDescription":60,"whoMasked":61},"SINGLE","The independent clinician who administers the HAM-D-17 is blind to group allocation. Participants are instructed not to reveal their allocation during assessments, and the assessor's guess of allocation is recorded at week 18 to evaluate blinding integrity. Participants and therapists cannot be blinded due to the nature of psychotherapy.",[62],"OUTCOMES_ASSESSOR","Background and rationale Major depressive disorder is a leading cause of disability worldwide. Cognitive behavioral therapy (CBT) is the most extensively studied psychotherapy for depression, and short-term psychodynamic\u002Fpsychoanalytic therapies have also shown efficacy in randomized trials. Direct comparisons of the two approaches remain limited, particularly in Türkiye, and few trials have examined whether each therapy works through its theoretically proposed mechanism.\n\nDesign Single-site, three-arm, parallel-group, randomized controlled trial with assessor-blinded outcome evaluation. Ninety adults with a DSM-5-TR diagnosis of major depressive disorder will be randomized in a 1:1:1 ratio to brief psychoanalytic therapy (BPT), CBT, or waitlist plus treatment as usual (WL-TAU).\n\nRandomization and allocation concealment A computer-generated sequence with permuted blocks of 3 and 6 will be prepared by a researcher not involved in recruitment, assessment or treatment. Randomization will be stratified by current antidepressant use (yes\u002Fno) and baseline severity (HAM-D-17 14-18 vs. 19 or higher). Allocation will be concealed in sequentially numbered, sealed, opaque envelopes opened only after baseline assessment.\n\nBlinding Clinician-rated outcomes (HAM-D-17) will be obtained by an independent assessor blind to group allocation. Participants will be instructed not to disclose their allocation. At week 18, the assessor will record a guess of each participant's group to evaluate blinding integrity. Participants and therapists cannot be blinded.\n\nInterventions Brief psychoanalytic therapy: 18 weekly individual sessions of 50 minutes, manualized according to Luborsky's supportive-expressive model and the unified protocol for short-term psychodynamic therapy of depression (Leichsenring \\& Schauenburg, 2014). Phases: alliance building and formulation of a focal Core Conflictual Relationship Theme (sessions 1-4); working through the focal conflict, defenses, self-criticism, loss and aggression, including here-and-now relational patterns (sessions 5-14); termination phase focusing on separation and loss (sessions 15-18).\n\nCBT: 18 weekly individual sessions of 50 minutes based on Beck's cognitive therapy for depression. Phases: psychoeducation and behavioral activation (sessions 1-4); identification and restructuring of automatic thoughts (sessions 5-12); modification of intermediate and core beliefs (sessions 13-16); relapse prevention (sessions 17-18). Structured homework is assigned each session.\n\nWaitlist plus treatment as usual: participants continue routine psychiatric follow-up with antidepressant doses held stable and receive no psychotherapy for 18 weeks. Brief non-therapeutic safety check-in calls are made every 4 weeks. After the week-18 assessment, participants are offered either active therapy.\n\nIn all arms, participants taking antidepressants must have been on a stable dose for at least 8 weeks before enrollment and agree to keep the dose unchanged during the 18-week treatment phase. Sessions may be completed within a window of up to 20 weeks to accommodate missed appointments.\n\nTherapists and treatment fidelity Each arm will be delivered by separate licensed clinical psychologists trained in the respective modality, with weekly supervision. All sessions will be audio-recorded with consent. A random 20% of sessions will be rated for adherence using the Comparative Psychotherapy Process Scale (psychodynamic-interpersonal and cognitive-behavioral subscales), and CBT sessions additionally with the Revised Cognitive Therapy Scale (CTS-R).\n\nAssessments Diagnosis will be established by a psychiatrist and confirmed with the Structured Clinical Interview for DSM-5, Clinician Version (SCID-5-CV). Outcomes will be assessed at baseline, week 9 and week 18 in all arms, and at 6- and 12-month follow-up in the two active arms. All instruments are used in their validated Turkish versions: Hamilton Depression Rating Scale (HAM-D-17), Beck Depression Inventory-II, Beck Anxiety Inventory, WHOQOL-BREF-TR, Automatic Thoughts Questionnaire, Defense Style Questionnaire-40, and Working Alliance Inventory (active arms, sessions 3 and 12).\n\nSafety monitoring Suicidal ideation will be monitored at every assessment (HAM-D item 3, BDI-II item 9) and weekly by therapists. Participants in any arm showing clinically significant deterioration (an increase of 25% or more in HAM-D-17 from baseline) or emergent suicide risk (HAM-D item 3 score of 3 or higher) will be referred immediately for appropriate clinical care. These participants will remain in the intention-to-treat analysis. Adverse events will be recorded throughout.\n\nSample size With 30 participants per arm, the study has 80% power (two-tailed alpha = .05) to detect a between-group effect of d = 0.80 for each active therapy versus waitlist, allowing for approximately 15% attrition. The study is not powered for equivalence or non-inferiority testing between the two active therapies; this comparison is exploratory.\n\nStatistical analysis Primary analyses will follow the intention-to-treat principle using linear mixed-effects models with group, time and group-by-time interaction as fixed effects, baseline HAM-D-17 as a covariate, and restricted maximum likelihood estimation for missing data. The two primary contrasts (BPT vs. WL-TAU; CBT vs. WL-TAU) will be adjusted with the Holm procedure. Response (reduction of 50% or more in HAM-D-17) and remission (HAM-D-17 of 7 or less) will be analyzed with logistic regression. Mediation analyses will test whether change in defense style (DSQ-40) and automatic thoughts (ATQ) mediates outcomes in BPT and CBT, respectively. A per-protocol analysis (at least 12 sessions attended) will serve as a sensitivity analysis.",[65,71,76],{"label":66,"type":67,"description":68,"interventionNames":69},"Brief Psychoanalytic Therapy","EXPERIMENTAL","Participants receive 18 weekly individual 50-minute sessions of manualized brief psychoanalytic therapy over 18 weeks. Participants on antidepressants continue a stable dose.",[70],"Behavioral: Brief Psychoanalytic Therapy",{"label":72,"type":67,"description":73,"interventionNames":74},"Cognitive Behavioral Therapy","Participants receive 18 weekly individual 50-minute sessions of manualized cognitive behavioral therapy over 18 weeks. Participants on antidepressants continue a stable dose.",[75],"Behavioral: Cognitive Behavioral Therapy",{"label":77,"type":78,"description":79,"interventionNames":52},"Waitlist Plus Treatment as Usual","NO_INTERVENTION","Participants continue routine psychiatric follow-up with antidepressant doses held stable and receive no psychotherapy for 18 weeks. Brief non-therapeutic safety check-in calls are made every 4 weeks. After the week-18 assessment, participants are offered either brief psychoanalytic therapy or cognitive behavioral therapy.",[81,85],{"type":82,"name":66,"description":83,"armGroupLabels":84,"otherNames":52},"BEHAVIORAL","Manualized brief psychoanalytic therapy based on Luborsky's supportive-expressive model and the unified protocol for short-term psychodynamic therapy of depression. Delivered as 18 weekly individual 50-minute sessions by licensed clinical psychologists trained in psychodynamic therapy. Focuses on a Core Conflictual Relationship Theme, defenses, self-criticism, loss and aggression, and includes a structured termination phase addressing separation and loss.",[66],{"type":82,"name":72,"description":86,"armGroupLabels":87,"otherNames":52},"Manualized cognitive behavioral therapy based on Beck's cognitive therapy for depression. Delivered as 18 weekly individual 50-minute sessions by licensed clinical psychologists trained in CBT. Includes psychoeducation, behavioral activation, cognitive restructuring of automatic thoughts, modification of intermediate and core beliefs, relapse prevention, and structured weekly homework.",[72],[89],{"name":90,"affiliation":91,"role":92},"Metin Çınaroğlu","Istanbul Nisantasi Universitesi","STUDY_CHAIR",[94,99],{"name":95,"role":96,"phone":97,"phoneExt":52,"email":98},"Metin Çınaroğlu, Phd","CONTACT","09053247320","metincinaroglu@gmail.com",{"name":100,"role":96,"phone":101,"phoneExt":52,"email":102},"Eda Yılmazer, Phd","+905322575880","laledayilmazer@gmail.com",[104],{"facility":91,"status":52,"city":105,"state":105,"zip":106,"country":107,"countryCode":52,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"Istanbul","34320","Turkey (Türkiye)",{"type":109,"coordinates":110},"Point",[111,112],28.94966,41.01384,{"lat":112,"lon":111},[115,117,118],{"name":95,"role":96,"phone":116,"phoneExt":52,"email":98},"+905324732070",{"name":100,"role":96,"phone":101,"phoneExt":52,"email":102},{"name":95,"role":119,"phone":52,"phoneExt":52,"email":52},"PRINCIPAL_INVESTIGATOR",{"type":119,"investigatorFullName":90,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":52,"oldOrganization":52},"Assistant Professor of Psychology",[123,125],{"name":124,"class":6},"Halic University",{"name":126,"class":6},"Uskudar University","100658869","brief-psychoanalytic-therapy-versus-cognitive-behavioral-therapy-for-major-depressive-disorder-100658869",false,"NCT07857629","Brief Psychoanalytic Therapy Versus Cognitive Behavioral Therapy for Major Depressive Disorder","Brief Psychoanalytic Therapy Versus Cognitive Behavioral Therapy for Major Depressive Disorder: A Three-Arm Randomized Controlled Trial","BPT-CBT-D","Inclusion Criteria:\n\n* Primary DSM-5-TR diagnosis of Major Depressive Disorder (single or recurrent episode), established by a psychiatrist and confirmed with the Structured Clinical Interview for DSM-5, Clinician Version (SCID-5-CV)\n* Hamilton Depression Rating Scale (HAM-D-17) total score of 14 or higher at baseline\n* Either not taking antidepressant medication, or on a stable antidepressant dose for at least 8 weeks before enrollment and willing to keep the dose unchanged during the 18-week treatment phase\n* Literate in Turkish and able to attend weekly sessions\n* Written informed consent\n\nExclusion Criteria:\n\n* Bipolar disorder, schizophrenia spectrum or other psychotic disorder, or major depressive disorder with psychotic features\n* Moderate or severe substance use disorder within the past 6 months\n* High suicide risk, defined as active suicidal ideation with plan or intent, or a suicide attempt within the past 12 months\n* Another primary psychiatric diagnosis requiring different treatment (e.g., posttraumatic stress disorder, obsessive-compulsive disorder, eating disorder, or severe personality disorder)\n* Neurological disorder, dementia, intellectual disability, or a medical condition that could explain the depressive symptoms (e.g., untreated hypothyroidism)\n* Currently receiving any psychotherapy, or having received cognitive behavioral or psychodynamic therapy within the past 12 months\n* Electroconvulsive therapy or repetitive transcranial magnetic stimulation within the past 6 months","ALL","18 Years","65 Years",{"count":139,"type":140},90,"ESTIMATED","INTERVENTIONAL",[143],"NA","The goal of this clinical trial is to learn whether brief psychoanalytic therapy and cognitive behavioral therapy (CBT) reduce depressive symptoms in adults aged 18 to 65 who have been diagnosed with major depressive disorder. The main questions it aims to answer are:\n\n* Does brief psychoanalytic therapy reduce depression severity more than a waitlist control condition after 18 weeks?\n* Does CBT reduce depression severity more than a waitlist control condition after 18 weeks?\n\nResearchers will also compare brief psychoanalytic therapy with CBT to explore whether one works better than the other, and will examine whether changes in defense mechanisms and automatic negative thoughts explain improvement in each therapy.\n\nParticipants will:\n\n* Be randomly assigned to brief psychoanalytic therapy, CBT, or a waitlist control group (30 participants per group)\n* In the therapy groups, attend 18 weekly individual therapy sessions of 50 minutes each\n* In the waitlist group, continue their usual psychiatric care without psychotherapy for 18 weeks, and then be offered one of the therapies\n* Complete clinical interviews and questionnaires about depression, anxiety, quality of life, thought patterns and coping styles before treatment, at week 9 and at week 18\n* In the therapy groups, complete follow-up assessments 6 and 12 months after treatment ends",[146],"Major Depressive Disorder (MDD",[148,149,150,72,151],"Psychodynamic Psychotherapy","Short-Term Psychoanalytic Therapy","Supportive-Expressive Therapy","Depression","NOT_YET_RECRUITING","2026-10-01",{"date":155,"type":156},"2026-10-05","ACTUAL",{"date":158,"type":140},"2026-11-01",{"date":160,"type":140},"2027-10-15",{"name":5,"class":6},1]