RCT of Short-Term Psychoanalytic vs. Cognitive Behavioral Therapy for GAD

NCT06831708 | Recruiting

• 1 other identifier: Beykoz Psychoanalysis vs CBT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial designed to compare the effectiveness of two types of short-term psychotherapy-psychoanalytic therapy and Cognitive Behavioral Therapy (CBT)-in treating Generalized Anxiety Disorder (GAD). A total of 60 adult participants with a confirmed diagnosis of GAD will be enrolled and randomly assigned to one of three groups: one group will receive psychoanalytic therapy, a second group will receive CBT, and a third group will serve as a control (waiting list) group. Each treatment group will participate in 12 weekly sessions, with each session lasting 50 minutes. In the psychoanalytic therapy group, therapy will follow a standardized framework based on core psychoanalytic principles such as exploring unconscious conflicts, transference, and resistance. While this approach is flexible, all therapists will be trained and calibrated to apply these core principles consistently. In contrast, the Cognitive Behavioral Therapy (CBT) group will receive a structured, manualized intervention specifically designed for Generalized Anxiety Disorder (GAD). The control group will not receive any active psychotherapy during the study period but will continue to receive any standard care they are already using. The primary outcome of the study will be the change in anxiety symptoms measured by the Beck Anxiety Inventory (BAI) from before treatment to after the 12 sessions. Secondary outcomes will include measures of quality of life (using the World Health Organization Quality of Life Instrument \[WHOQOL-BREF\]), depressive symptoms (using the Beck Depression Inventory-II \[BDI-II\]), functional impairment (using the World Health Organization Disability Assessment Schedule II \[WHODAS II\]), the quality of the therapeutic relationship (using the Working Alliance Inventory \[WAI\]), and overall treatment satisfaction. The study is designed to be completed within a six-month period: one month for recruitment, one month for baseline assessments and clinical checks, and three months for the intervention. Data will be collected at baseline and immediately after the intervention, with the goal of analyzing and publishing the results as soon as possible following treatment completion. This study has received ethical approval from the Üsküdar University Ethics Committee and is intended to inform future research on effective treatments for Generalized Anxiety Disorder (GAD).

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Psychoanalytic Therapy; Cognitive Behavioral Therapy; RCT; Anxiety; Short-Term Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Beck Anxiety Inventory (BAI)

  The primary outcome is the change in anxiety severity measured by the Beck Anxiety Inventory (BAI), a 21-item self-report scale rated from 0 ("Not at all") to 3 ("Severely"). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity: 0-7 (minimal), 8-15 (mild), 16-25 (moderate), and 26-63 (severe). The BAI will be administered at baseline and after 12 weekly sessions. The primary analysis will compare changes in BAI scores across the three study arms (psychoanalytic therapy, Cognitive Behavioral Therapy \[CBT\], and control) to assess treatment efficacy for Generalized Anxiety Disorder (GAD).

  Baseline (pre-treatment) and immediately post-treatment (after completion of 12 weekly sessions, approximately 3 months after baseline)

Secondary Outcomes (4)

• World Health Organization Quality of Life (WHOQOL-BREF Score)

  Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions, approximately 3 months after baseline)

• Beck Depression Inventory (BDI-II Score)

  Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)

• World Health Organization Disability Assessment Schedule II (WHODAS II Score)

  Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)

• The Working Alliance Inventory (WAI Score)

  Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)

Study Arms (3)

Psychoanalytic Therapy

EXPERIMENTAL

Participants in this arm will receive short-term psychoanalytic therapy delivered via a standardized framework. Although the approach is not strictly manualized, a set of core principles (including exploration of unconscious conflicts, transference, and resistance) will guide therapy. The therapy will be administered in 12 weekly sessions, each lasting 50 minutes, by two of the study authors trained in this approach.

Behavioral: Psychoanalytic Psychotherapy

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

Participants in this arm will receive a structured, manualized cognitive behavioral therapy (CBT) intervention specifically designed for the treatment of Generalized Anxiety Disorder (GAD). Therapy will consist of 12 weekly sessions, each 50 minutes in duration, delivered by two of the study authors with specialized CBT training.

Behavioral: Cognitive Behavioral Therapy (CBT)

Control (Waiting List)

NO INTERVENTION

Participants in this arm will be placed on a waiting list for treatment. They will not receive any active psychotherapeutic intervention during the study period but may continue any standard care they are already receiving.

Interventions

Psychoanalytic Psychotherapy BEHAVIORAL

This intervention involves short-term psychoanalytic therapy based on a standardized framework. Although not rigidly manualized, the treatment protocol includes core psychoanalytic concepts (such as transference, resistance, and the exploration of unconscious conflicts). Sessions will be conducted weekly (50 minutes each) for a total of 12 sessions. This intervention is delivered by two study authors who have undergone dedicated training and calibration to ensure consistent application of the framework.

Psychoanalytic Therapy

Cognitive Behavioral Therapy (CBT) BEHAVIORAL

This intervention consists of a structured and manualized CBT program specifically tailored for individuals with Generalized Anxiety Disorder (GAD). The intervention includes defined session objectives, cognitive restructuring techniques, behavioral experiments, and homework assignments. Participants will receive 12 weekly sessions (50 minutes each), delivered by two study authors who are trained in CBT.

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years.
• A confirmed diagnosis of Generalized Anxiety Disorder (GAD) according to DSM-5 criteria, with the diagnosis made within the past 2 years.
• No participation in any form of psychotherapy during the past 6 months.
• Ability and willingness to attend 12 weekly therapy sessions (50 minutes each) over the 3-month intervention period.
• For participants receiving online sessions: access to a stable internet connection and the necessary technology.
• Ability to understand and provide written informed consent.

You may not qualify if:

• Presence of significant comorbid psychiatric disorders that could interfere with participation or assessment (e.g., bipolar disorder, psychotic disorders, substance use disorders, eating disorders).
• Recent changes in psychotropic medication (i.e., medication changes within the past 3 months, unless on a stable dose).
• Severe medical or neurological conditions that may interfere with study participation or data interpretation.
• Current participation in another clinical trial or structured psychotherapy program.
• Any condition that, in the opinion of the investigators, would compromise the safety or compliance of the participant in the study.

Sponsors & Collaborators

• Beykoz University: lead
• Uskudar University: collaborator
• Istanbul Nisantasi University: collaborator

Study Sites (1)

Beykoz University

Istanbul, 34820, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Anxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eda Yılmazer, Phd

  Beykoz University

  PRINCIPAL INVESTIGATOR

• Metin Çınaroğlu, Phd

  Istanbul Nisantasi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eda Yılmazer, Phd

CONTACT

+90532-257-58-80; edayilmazer@beykoz.edu.tr

Metin Çınaroğlu, Phd

CONTACT

+90532-473-20-70; metin.cinaroglu@nisantasi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There is no masking in this study. All participants and study personnel will be aware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Participants will be randomly assigned into one of three parallel arms: a psychoanalytic therapy arm, a CBT arm, or a control (waiting list) arm. Each arm will consist of 20 participants, with interventions delivered over 12 weekly sessions.

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 18, 2025
• Study Start: February 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be made available beginning 6 months after publication of the primary manuscript in a peer-reviewed journal and will remain available for a period of 5 years thereafter.
• Access Criteria: Access to the IPD and supporting documentation will be granted to qualified researchers who submit a methodologically sound research proposal. Data will be provided through a secure data access portal following review and approval by the study team. Researchers will be required to sign a data use agreement to ensure the data are used solely for research purposes and in compliance with applicable privacy regulations.

Locations

TU (1)