Clinical trial NCT06831708: RCT of Short-Term Psychoanalytic vs. Cognitive Behavioral Therapy for GAD
Official title: A Randomized Controlled Trial Comparing Short-Term Psychoanalytic Therapy and Cognitive Behavioral Therapy for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder
Psychoanalytic Therapy
Cognitive Behavioral Therapy
RCT
Anxiety
Short-Term Psychotherapy
Lead sponsor: Beykoz University
Sponsor class: OTHER
Collaborators: name: Uskudar University
name: Istanbul Nisantasi University
First posted: 2025-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned into one of three parallel arms: a psychoanalytic therapy arm, a CBT arm, or a control (waiting list) arm. Each arm will consist of 20 participants, with interventions delivered over 12 weekly sessions.
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck Anxiety Inventory (BAI)
timeFrame: Baseline (pre-treatment) and immediately post-treatment (after completion of 12 weekly sessions, approximately 3 months after baseline)
Secondary outcomes:
measure: World Health Organization Quality of Life (WHOQOL-BREF Score)
timeFrame: Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions, approximately 3 months after baseline)
measure: Beck Depression Inventory (BDI-II Score)
timeFrame: Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)
measure: World Health Organization Disability Assessment Schedule II (WHODAS II Score)
timeFrame: Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)
measure: The Working Alliance Inventory (WAI Score)
timeFrame: Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Beykoz University
Study officials:
affiliation: Beykoz University
name: Eda Yılmazer, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Nisantasi University
name: Metin Çınaroğlu, Phd
role: PRINCIPAL_INVESTIGATOR
References: