Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT
Launched by THEODORA ANASTASIOU · May 8, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a type of therapy called Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for unaccompanied refugee minors aged 15 to 18 in Greece who are experiencing symptoms of Post-Traumatic Stress Disorder (PTSD) and related issues like depression and anxiety. The goal is to see if this therapy can help reduce their PTSD symptoms more effectively than the usual treatment they currently receive. Participants will be randomly assigned to either the TF-CBT group or a control group that continues with standard care. The therapy will be provided by trained psychologists who understand the unique challenges faced by refugee youth.
To be eligible for the trial, participants must have arrived in Greece alone and have a diagnosis of PTSD. They should live in a designated accommodation center or supportive living program and have a stable living situation for a few weeks before starting the therapy. Importantly, those with certain severe mental health issues, like significant risk of self-harm or certain developmental disorders, will not be included. Throughout the study, participants will complete assessments at the beginning, after the therapy, and three months later to track changes in their mental health and quality of life. This research aims to find the best ways to support young refugees dealing with trauma.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Be unaccompanied upon arrival in Greece and aged between 15-18 years old.
- • Being diagnosed with PTSD based on DSM-5 criteria. Young refugees with post-traumatic stress symptoms (PTSS), as delineated by high or moderate trauma-related distress in the Child and Adolescent Trauma Screen (CATS), will also be eligible to participate in the study.
- • Reside in an accommodation center or SIL program for UAMs in Greece.
- • Have a stable living arrangement for at least 2-3 weeks prior to the intervention.
- • Not be expected to relocate within the 2-3 months following the start of the intervention.
- Exclusion Criteria:
- • a diagnosed intellectual disability (IQ \< 70) or another developmental disorder
- • acute suicidality or life-threatening self-harm behavior
- • significant risk of harm to others
- • comorbidity with bipolar disorder or a psychotic disorder
- • substance abuse.
About Theodora Anastasiou
Theodora Anastasiou is a dedicated clinical trial sponsor focused on advancing medical research and improving patient outcomes. With a commitment to innovative methodologies and rigorous ethical standards, the organization collaborates with healthcare professionals, researchers, and regulatory bodies to facilitate the development of safe and effective therapeutic interventions. By leveraging a diverse portfolio of clinical studies across various therapeutic areas, Theodora Anastasiou aims to contribute significantly to the scientific community and enhance the quality of care for patients globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Athens, , Greece
Patients applied
Trial Officials
Vasiliki Yotsidi, PhD
Study Chair
Panteion University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported