An interventional study of Brief Psychoanalytic Therapy and Cognitive Behavioral Therapy in Major Depressive Disorder (MDD, sponsored by Istanbul Nisantasi University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Istanbul Nisantasi University · Not applicable, Interventional, and Treatment
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:
Researchers 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.
Participants will:
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/psychoanalytic 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.
Design 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).
Randomization 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/no) 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.
Blinding 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.
Interventions 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).
CBT: 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.
Waitlist 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.
In 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.
Therapists 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).
Assessments 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).
Safety 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.
Sample 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.
Statistical 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.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Istanbul Nisantasi University is the lead sponsor of 20 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Participants receive 18 weekly individual 50-minute sessions of manualized brief psychoanalytic therapy over 18 weeks. Participants on antidepressants continue a stable dose.
Behavioral: Brief Psychoanalytic Therapy
Participants receive 18 weekly individual 50-minute sessions of manualized cognitive behavioral therapy over 18 weeks. Participants on antidepressants continue a stable dose.
Behavioral: Cognitive Behavioral Therapy
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.
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.
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.
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.
Time frame: Baseline, week 9, and week 18
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.
Time frame: Baseline, week 9, and week 18
Treatment Response Rate
Percentage of participants achieving a reduction of 50% or more in HAM-D-17 total score from baseline.
Time frame: Week 18
Remission Rate
Percentage of participants with a HAM-D-17 total score of 7 or less.
Time frame: Week 18
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.
Time frame: Baseline, week 9, and week 18
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.
Time frame: Baseline and week 18
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.
Time frame: Baseline, week 9, and week 18
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.
Time frame: Baseline, week 9, and week 18
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.
Time frame: Week 3 and week 12
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.
Time frame: 6 months and 12 months after the end of treatment (approximately week 44 and week 70 from baseline)
Treatment Dropout and Session Attendance
Percentage of participants discontinuing treatment before session 12, and mean number of sessions attended per arm.
Time frame: Up to 20 weeks
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.
Time frame: Up to 20 weeks
Plan to share: Yes — De-identified individual participant data underlying the published results (baseline characteristics and all primary and secondary outcome measures) will be made available to qualified researchers upon reasonable request to the principal investigator.
Supporting information: Study protocol, Sap
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Istanbul Nisantasi University