Trauma-Focused Cognitive Behavioral Therapy in Unaccompanied Refugee Minors With PTSD in Greece: An RCT
Recruiting now · Not applicable
Conditions studied: Post-Traumatic Stress Disorder (PTSD), Depressive Symptoms, Anxiety Symptoms, Somatic Symptoms, Emotional and Behavioral Difficulties
In brief
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.
Key facts
- Study ID
- NCT06975280
- Run by
- Theodora Anastasiou
- People needed
- 60
- Starts
- 2023-04-13
- Expected to finish
- 2026-02-01
- Last updated by the study team
- 2025-05-16
Who can join
Age: 15 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- General Secretariat for Vulnerable Persons and Institutional Protection, Ministry of Migration and Asylum — Athens, Greece (enrolling)
Full record on ClinicalTrials.gov
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