Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT

This single-blinded, multicentered, randomized controlled trial aims to evaluate the effectiveness of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) compared to Treatment-as-Usual (TAU) in reducing post-traumatic stress symptoms among unaccompanied refugee minors (UAMs) residing in accommodation centers and Supported Independent Living (SIL) programs in Greece. Participants aged 15-18 will be randomly assigned to either a TF-CBT intervention group or a TAU control group. The intervention will be delivered by trained psychologists under supervision and culturally adapted to the Greek refugee context. Assessments will occur at baseline, post-intervention, and three months later, using standardized psychometric tools. Secondary outcomes include changes in comorbid psychiatric symptoms (depression, anxiety, somatic symptoms), emotional and behavioral difficulties, and quality of life. The study also investigates potential moderators of treatment response such as age, gender, trauma history, and psychiatric comorbidity.

NCT Number	NCT06975280
Lead Sponsor	Theodora Anastasiou Collaborators: Greek Ministry of Migration and Asylum, SOS Children's Villages
Conditions	Post-Traumatic Stress Disorder (PTSD), Depressive Symptoms, Anxiety Symptoms, Somatic Symptoms, Emotional and Behavioral Difficulties
Enrollment	60 participants
Start Date	2023-04-13
Primary Completion	2025-12 (estimated)
Study Completion	2026-02 (estimated)
Updated on ClinicalTrials.gov	2025-05-16