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

Condition(s) studied

Investigational drug(s) / intervention(s)

Psychoanalytic Psychotherapy: 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.

Cognitive Behavioral Therapy (CBT): 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.

Study 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).

Eligibility

Primary outcome measure(s)

• Beck Anxiety Inventory (BAI) — Baseline (pre-treatment) and immediately post-treatment (after completion of 12 weekly sessions, approximately 3 months after baseline)
  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).

Trial sites (1)

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