RCT of Short-Term Psychoanalytic vs. Cognitive Behavioral Therapy for GAD
Recruiting · NCT06831708 · Interventional (participants receive a specific treatment) · Lead sponsor: Beykoz University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Beykoz University - Istanbul, Turkey (Türkiye)