Actively Recruiting
Implementation, Cultural Adaptation, and Efficacy Evaluation of Trauma-Focused Cognitive Behavioral Therapy for Unaccompanied Refugee Minors in Greece
Led by Theodora Anastasiou · Updated on 2025-05-16
60
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
Theodora Anastasiou
Lead Sponsor
G
Greek Ministry of Migration and Asylum
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) compared to Treatment-as-Usual (TAU) for unaccompanied refugee minors aged 15 to 18 years living in accommodation centers and Supported Independent Living programs in Greece. This randomized controlled trial aims to reduce post-traumatic stress symptoms and assess secondary outcomes like depression, anxiety, somatic symptoms, emotional and behavioral difficulties, and quality of life. The study also examines factors like age, gender, trauma history, and psychiatric comorbidity that might affect treatment response. Participants are randomly assigned to either the TF-CBT intervention or TAU control group. The TF-CBT group receives a structured, culturally adapted therapy over 12 weekly or bi-weekly sessions, including psychoeducation, relaxation, cognitive restructuring, trauma processing, and safety planning, delivered by trained psychologists under supervision. The TAU group receives routine clinical management and general psychological support without a structured therapeutic framework. Psychologists are also randomly assigned to groups and trained accordingly. Assessments occur at baseline, immediately after intervention, and three months later. During the study, participants complete standardized questionnaires in their preferred language, including the Child and Adolescent Trauma Screen, Depression Anxiety Stress Scale, Physical Health Questionnaire, Strengths and Difficulties Questionnaire, and WHO-5 Well-Being Index. Data collection is anonymous and electronic. Psychologists oversee assessments but do not access data, while interpreters assist as needed. The study includes collaboration with trained interpreters and follows ethical guidelines to ensure confidentiality. The total involvement includes intervention delivery and follow-up assessments over several months.
CONDITIONS
Brief Title
Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be unaccompanied upon arrival in Greece and aged between 15-18 years old.
- Diagnosed with PTSD based on DSM-5 criteria or show moderate to high trauma-related distress on the Child and Adolescent Trauma Screen (CATS).
- Reside in an accommodation center or Supported Independent Living program for unaccompanied minors in Greece.
- Have a stable living arrangement for at least 2-3 weeks before the intervention.
- Not expected to relocate within 2-3 months after starting the intervention.
You will not qualify if you...
- Diagnosed intellectual disability (IQ less than 70) or other developmental disorders.
- Acute suicidality or recent severe self-injurious behavior.
- Significant risk of harm to others.
- Comorbidity with bipolar disorder or psychotic disorders.
- Ongoing substance abuse or active addiction.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants in the intervention group receive Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), a structured therapeutic protocol delivered over 12 weekly or bi-weekly sessions by trained psychologists. This therapy includes psychoeducation, relaxation, emotional regulation, cognitive processing, trauma narrative, and safety planning. Participants in the control group receive routine clinical management and general psychological support without a structured therapeutic framework.
Weekly or bi-weekly visits for up to 12 weeks
Duration - 3 months post-intervention
Participants are assessed immediately after the intervention and again 3 months later to evaluate changes in PTSD symptoms, emotional well-being, and overall mental health.
2 visits (immediately post-intervention and at 3-month follow-up)
Trial Site Locations
Total: 1 location
1
General Secretariat for Vulnerable Persons and Institutional Protection, Ministry of Migration and Asylum
Athens, Greece, 182 33
Actively Recruiting
Research Team
T
Theodora Anastasiou, PhD candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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