This randomized controlled trial (RCT) is designed to rigorously compare the clinical outcomes of two psychotherapeutic interventions for Generalized Anxiety Disorder (GAD)-short-term psychoanalytic therapy and Cognitive Behavioral Therapy (CBT)-against a control (waiting list) condition. The study will be conducted at a single center with a total sample of 60 participants who have been diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria within the past two years. Participants will be stratified and randomly assigned in equal numbers (n=20 per group) to one of the three study arms.
Intervention Details:
Psychoanalytic Therapy Arm:
Although psychoanalytic therapy is inherently flexible and individualized, for the purposes of this study a standardized framework will be employed. This framework is based on core psychoanalytic principles such as the exploration of unconscious conflicts, the dynamics of transference, and the management of resistance. The approach is not rigidly manualized; instead, it is standardized through:
Pre-intervention Training: Therapists will engage in specific training sessions to discuss and agree on key therapeutic elements and session structure.
Calibration Meetings: Regular meetings will be held to ensure consistent application of the framework.
Fidelity Monitoring: A session checklist will be utilized to document the presence of core components in each session. Selected sessions may be recorded (with participant consent) for review by an independent clinician to ensure adherence to the agreed-upon framework.
Cognitive Behavioral Therapy (CBT) Arm:
The CBT intervention will follow a structured, manualized protocol tailored specifically for treating GAD. This intervention includes:
Manualized Sessions: Each of the 12 weekly sessions (50 minutes each) will have defined objectives, cognitive restructuring techniques, behavioral experiments, and homework assignments.
Standardization and Supervision: Therapists will receive training in the manualized approach and undergo regular supervision, including periodic review of session recordings and fidelity checklists to ensure strict adherence to the protocol.
Control Arm:
Participants in the control group will be placed on a waiting list for treatment. They will not receive any active psychotherapeutic intervention during the study period, although they may continue any ongoing standard care. This group is included to control for the effects of time and natural fluctuations in anxiety symptoms.
Assessment and Outcome Measures:
Data will be collected at two time points: at baseline (prior to the start of the intervention) and immediately following the completion of the 12-week intervention phase. The primary outcome measure is the change in anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI). Secondary outcomes include:
Quality of Life: Measured by the World Health Organization Quality of Life Instrument (WHOQOL-BREF).
Depressive Symptoms: Measured by the Beck Depression Inventory-II (BDI-II). Functional Impairment: Assessed using the World Health Organization Disability Assessment Schedule II (WHODAS II).
Therapeutic Alliance: Evaluated via the Working Alliance Inventory (WAI), administered after the third session.
Treatment Satisfaction: Assessed through a post-treatment satisfaction questionnaire.
Study Timeline:
Recruitment Period: Approximately one month will be dedicated to recruiting the required sample.
Baseline Assessment and Clinical Evaluation: A subsequent one-month period will be used to perform baseline assessments, including a clinical evaluation by a collaborating psychiatrist.
Intervention Phase: Over the next three months, participants will undergo 12 weekly therapy sessions.
Post-Treatment Evaluation: Data collection for outcome measures will occur immediately following the intervention, allowing for timely analysis and dissemination of results.
Data Handling and Analysis:
Data collection will be executed using secure online platforms for questionnaires and standardized assessment tools. Clinical evaluations may be conducted in-person or via secure video conferencing, ensuring flexibility and participant convenience. All data will be anonymized and stored in compliance with current data protection regulations.
The statistical analysis will primarily focus on changes in Beck Anxiety Inventory (BAI) scores using Analysis of Variance (ANOVA) or repeated measures ANOVA to compare the effects between the three groups. Secondary outcome measures will be analyzed similarly. An intention-to-treat (ITT) analysis will be applied, including all participants randomized to the study, to preserve the benefits of randomization and reduce bias. Data analysis will be carried out using validated statistical software packages such as Statistical Package for the Social Sciences (SPSS) or R.
Ethical and Administrative Considerations:
The study has received ethical approval from the Üsküdar University Ethics Committee. Written informed consent will be obtained from all participants prior to enrollment. The study has been designed with strict adherence to ethical standards to ensure participant safety, confidentiality, and data integrity.
This protocol has been structured to enable rapid completion of the study within a six-month period while providing robust and reliable data. The outcomes of this study are expected to inform clinical practice by clarifying the comparative effectiveness of a structured Cognitive Behavioral Therapy (CBT) intervention versus a standardized framework for psychoanalytic therapy in the treatment of Generalized Anxiety Disorder (GAD). Future studies may extend these findings by including longer follow-up periods to assess the durability of therapeutic effects.
