Brief Psychoanalytic Therapy Versus Cognitive Behavioral Therapy for Major Depressive Disorder (BPT-CBT-D)

Brief Psychoanalytic Therapy Versus Cognitive Behavioral Therapy for Major Depressive Disorder: A Three-Arm Randomized Controlled Trial

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:

• Does brief psychoanalytic therapy reduce depression severity more than a waitlist control condition after 18 weeks?
• Does CBT reduce depression severity more than a waitlist control condition after 18 weeks?

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:

• Be randomly assigned to brief psychoanalytic therapy, CBT, or a waitlist control group (30 participants per group)
• In the therapy groups, attend 18 weekly individual therapy sessions of 50 minutes each
• In the waitlist group, continue their usual psychiatric care without psychotherapy for 18 weeks, and then be offered one of the therapies
• 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
• In the therapy groups, complete follow-up assessments 6 and 12 months after treatment ends

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder (MDD
• Intervention / Treatment: Behavioral: Brief Psychoanalytic Therapy; Behavioral: Cognitive Behavioral Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Metin Çınaroğlu, Phd; Phone Number: 09053247320; Email: metincinaroglu@gmail.com
• Study Contact Backup: Name: Eda Yılmazer, Phd; Phone Number: +905322575880; Email: laledayilmazer@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34320
      • Istanbul Nisantasi Universitesi
      • Principal Investigator: Metin Çınaroğlu, Phd
      • Contact: Metin Çınaroğlu, Phd; Phone Number: +905324732070; Email: metincinaroglu@gmail.com
      • Contact: Eda Yılmazer, Phd; Phone Number: +905322575880; Email: laledayilmazer@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)
• Hamilton Depression Rating Scale (HAM-D-17) total score of 14 or higher at baseline
• 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
• Literate in Turkish and able to attend weekly sessions
• Written informed consent

Exclusion Criteria:

• Bipolar disorder, schizophrenia spectrum or other psychotic disorder, or major depressive disorder with psychotic features
• Moderate or severe substance use disorder within the past 6 months
• High suicide risk, defined as active suicidal ideation with plan or intent, or a suicide attempt within the past 12 months
• Another primary psychiatric diagnosis requiring different treatment (e.g., posttraumatic stress disorder, obsessive-compulsive disorder, eating disorder, or severe personality disorder)
• Neurological disorder, dementia, intellectual disability, or a medical condition that could explain the depressive symptoms (e.g., untreated hypothyroidism)
• Currently receiving any psychotherapy, or having received cognitive behavioral or psychodynamic therapy within the past 12 months
• Electroconvulsive therapy or repetitive transcranial magnetic stimulation within the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief Psychoanalytic Therapy; 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; 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.
Experimental: 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.	Behavioral: Cognitive Behavioral Therapy; 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.
No Intervention: 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 brief psychoanalytic therapy or cognitive behavioral therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 18
Remission Rate	Percentage of participants with a HAM-D-17 total score of 7 or less.	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.	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.	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.	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.	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.	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.	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.	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.	Up to 20 weeks

Collaborators and Investigators

• Sponsor: Istanbul Nisantasi University
• Collaborators: Halic University; Uskudar University
• Investigators: Study Chair: Metin Çınaroğlu, Istanbul Nisantasi Universitesi

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): October 15, 2027

Study Registration Dates

• First Submitted: September 27, 2026
• First Submitted That Met QC Criteria: October 1, 2026
• First Posted (Actual): October 5, 2026

Study Record Updates

• Last Update Posted (Actual): October 5, 2026
• Last Update Submitted That Met QC Criteria: October 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Cognitive Behavioral Therapy; Psychodynamic Psychotherapy; Short-Term Psychoanalytic Therapy; Supportive-Expressive Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depressive Disorder; Behavior; Depression; Depressive Disorder, Major; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy
• Other Study ID Numbers: INU-EK-2026.03-BPTCBT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months after publication of the primary results and ending 5 years after publication.

IPD Sharing Access Criteria

Requests must include a methodologically sound proposal and be directed to the principal investigator (metincinaroglu@gmail.com). Data will be shared after approval of the proposal and signing of a data use agreement, in accordance with Turkish personal data protection law (KVKK) and the approving ethics committee's requirements.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No