NFB4Ukraine – neurofeedback interventions for combat-related post-traumatic stress disorder in Ukraine

INTERVENTION: This is a five‐arm, prospective, parallel‐group randomised controlled trial (RCT) with an equal 1:1:1:1:1 allocation ratio. Participants are randomly assigned to one of five conditions: (1) TAU + ILF‐Neurofeedback (2) TAU + Narrative Exposure Therapy (NET) (3) TAU + ILF‐Neurofeedback + NET (combined) (4) TAU + Visual Relaxation (active control) (5) TAU / Wait‐list control Randomisation is performed using a computer‐generated block randomisation sequence (block sizes of 10 and 15) generated by an independent researcher not involved in recruitment, intervention delivery, or outcome assessment. Group assignment is concealed using sequentially numbered, sealed, opaque envelopes, opened by the study therapist after completion of the baseline assessment (T1). The intervention phase lasts 6± weeks for all active groups: ‐ ILF‐Neurofeedback: 10‐15 sessions (30‐45 min each), using the Othmer method (Cygnet software), targeting central nervous system arousal regulation. ‐ NET: 8‐12 sessions following the standard Narrative Exposure Therapy protocol, a short‐term trauma‐focused intervention in which participants construct a chronological narrative of their life while repeatedly and systematically processing traumatic memories within their autobiographical context, using a "lifeline" technique. ‐ Visual Relaxation: 10‐15 sessions viewing neutral/calming nature videos (active control for therapist contact time). ‐ TAU: standard clinical care provided by the military hospital (e.g. CBT, Prolonged Exposure, EMDR, per Ministry of Health protocols). Participants remain blinded to their group allocation throughout the study. Therapists are blinded until the envelope is opened, after which they are informed of the assigned condition to deliver the appropriate protocol. Outcome assessors and data analysts remain blinded to group allocation throughout (assessor‐blind design). Assessments occur at baseline (T1, before randomisation), post‐intervention (T2, immediately after the 6±‐week intervention), and at one‐month follow‐up (T3). A qualitative component (semi‐structured interviews with a purposive subsample of 15 participants, 3 per arm) is conducted between T2 and T3 to explore treatment acceptability and participant experience. CONDITION: Post‐traumatic stress disorder (PTSD) in Ukrainian military personnel (combat‐related trauma) ; Mental and Behavioural Disorders PRIMARY OUTCOME: PTSD symptom severity (change in PCL‐5 total score from baseline to post‐intervention) measured using PTSD Checklist for DSM‐5 (PCL‐5), a 20‐item self‐report measure assessing the severity of PTSD symptoms at Baseline (T1, before randomisation) and post‐intervention (T2, immediately after the 6±‐week intervention) INCLUSION CRITERIA: 1. Ukrainian military personnel (men and women) 2. Age 18‐60 years 3. Primary diagnosis of post‐traumatic stress disorder (PTSD) according to DSM‐5, confirmed via Structured Clinical Interview for DSM‐5 (SCID‐5) 4. PTSD Checklist for DSM‐5 (PCL‐5) total score =33