RCT of Short-Term Psychoanalytic vs. Cognitive Behavioral Therapy for GAD
ConditionGeneralized Anxiety Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeykoz University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Psychoanalytic Psychotherapy
BehavioralThis 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)
BehavioralThis 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Psychoanalytic TherapyExperimental treatment 1 intervention
Group B: Cognitive Behavioral Therapy (CBT)Experimental treatment 1 intervention
Group C: Control (Waiting List)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Beck Anxiety Inventory (BAI)
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).
Time frame
Baseline (pre-treatment) and immediately post-treatment (after completion of 12 weekly sessions, approximately 3 months after baseline)Secondary outcomes
1
World Health Organization Quality of Life (WHOQOL-BREF Score)
The WHOQOL-BREF is a 26-item self-report questionnaire assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Each item is rated on a 5-point Likert scale, with higher scores indicating better quality of life. Domain scores range from 4 to 20 and can be transformed to a 0-100 scale. The WHOQOL-BREF will be administered at baseline and post-intervention to assess treatment impact on quality of life in individuals with Generalized Anxiety Disorder (GAD).
Time frame
Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions, approximately 3 months after baseline)2
Beck Depression Inventory (BDI-II Score)
The BDI-II is a 21-item self-report questionnaire assessing depressive symptom severity over the past two weeks. Each item is rated from 0 to 3, with total scores ranging from 0 to 63 (higher scores indicating more severe depression): 0-13 (minimal), 14-19 (mild), 20-28 (moderate), 29-63 (severe). The BDI-II will be administered at baseline and post-treatment to assess changes in depressive symptoms in participants with Generalized Anxiety Disorder (GAD).
Time frame
Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)3
World Health Organization Disability Assessment Schedule II (WHODAS II Score)
The WHODAS II is a 36-item questionnaire assessing functioning across six domains: cognition, mobility, self-care, getting along, life activities, and participation. Each item is rated on a 5-point scale, with total scores ranging from 0 (no disability) to 100 (full disability). Higher scores indicate greater functional impairment. The WHODAS II will be administered at baseline and post-treatment to assess changes in daily functioning and disability levels.
Time frame
Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)4
The Working Alliance Inventory (WAI Score)
The WAI is a self-report questionnaire assessing the therapeutic relationship across three components: goal agreement, task consensus, and bond development. The original 36-item WAI uses a 7-point scale (1 = never, 7 = always), with higher scores indicating a stronger alliance. The 12-item WAI-Short Form (WAI-S) is often used in clinical settings. The WAI will be administered after the third session to assess the therapeutic relationship's role in treatment outcomes for Generalized Anxiety Disorder (GAD).
Time frame
Baseline (pre-treatment) and Immediately Post-Treatment (after 12 sessions)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beykoz University
Lead sponsor
Uskudar University
Collaborator
Istanbul Nisantasi University
Collaborator
Source ClinicalTrials.gov