Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06831708

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

Led by Beykoz University · Updated on 2025-02-18

60

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

B

Beykoz University

Lead Sponsor

U

Uskudar University

Collaborating Sponsor

AI-Summary

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years.
  • Confirmed diagnosis of Generalized Anxiety Disorder (GAD) according to DSM-5 criteria 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 3 months.
  • Access to a stable internet connection and necessary technology for online sessions.
  • Ability to understand and provide written informed consent.
Not Eligible

You will not qualify if you...

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

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Trial Site Locations

Total: 1 location

1

Beykoz University

Istanbul, Turkey (Türkiye), 34820

Actively Recruiting

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Research Team

E

Eda Yılmazer, Phd

CONTACT

M

Metin Çınaroğlu, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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