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

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).

NCT Number	NCT06831708
Lead Sponsor	Beykoz University Collaborators: Uskudar University, Istanbul Nisantasi University
Conditions	Generalized Anxiety Disorder
Enrollment	60 participants
Start Date	2025-02-01
Primary Completion	2025-08-01 (estimated)
Study Completion	2025-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-02-18