The HortONS study. Treatment of chronic cluster headache with transcutaneous electrical nerve stimulation and occipital nerve stimulation: study protocol for a prospective, investigator-initiated, double-blinded, randomized, placebo-controlled trial.

BACKGROUND: Chronic cluster headache (CCH) is a debilitating primary headache disorder. Occipital nerve stimulation (ONS) has shown the potential to reduce attack frequency, but the occipital paresthesia evoked by conventional (tonic) stimulation challenges a blinded comparison of active stimulation and placebo. Burst ONS offers paresthesia-free stimulation, enabling a blinded, placebo-controlled study. Identification of a feasible preoperative test would help select the best candidates for implantation. This study aims to explore ONS as a preventive treatment for CCH, comparing burst stimulation to tonic stimulation and placebo, and possibly identifying a potential preoperative predictor. METHODS: An investigator-initiated, double-blinded, randomized, placebo-controlled trial is conducted, including 40 patients with CCH. Eligible patients complete a trial with the following elements: I) four weeks of baseline observation, II) 12 weeks of transcutaneous electrical nerve stimulation (TENS) of the occipital nerves, III) implantation of a full ONS system followed by 2 week grace period, IV) 12 weeks of blinded trial with 1:1 randomization to either placebo (deactivated ONS system) or burst (paresthesia-free) stimulation, and V) 12 weeks of tonic stimulation. The primary outcomes are the reduction in headache attack frequency with TENS and ONS and treatment safety. Secondary outcomes are treatment efficacy of burst versus tonic ONS, the feasibility of TENS as a predictor for ONS outcome, reduction in headache pain intensity (numeric rating scale), reduction in background headache, the patient's impression of change (PGIC), health-related quality of life (EuroQoL-5D), self-reported sleep quality, and symptoms of anxiety and depression (Hospital Anxiety and Depression Scale, HADS). Data on headache attack characteristics are registered weekly. Data on patient-reported outcomes are assessed after each trial phase. DISCUSSION: The study design allows a comparison between burst ONS and placebo in refractory CCH and enables a comparison of the efficacy of burst and tonic ONS. It will provide information about the effect of burst ONS and explore whether the addition of this stimulation paradigm may improve stimulation protocols. TENS is evaluated as a feasible preoperative screening tool for ONS outcomes by comparing the effect of attack prevention of TENS and tonic ONS. TRIAL REGISTRATION: The study is registered at Clinicaltrials.gov (trial registration number NCT05023460, registration date 07-27-2023).

Integrating Mental Health and Psychosocial Support Into Health Facilities in Conflict Settings: A Retrospective Review From Six African Countries.

Introduction: The International Committee of the Red Cross runs an increasing number of mental health and psychosocial programmes integrated into health facilities in conflict settings across Africa. This study looks at changes in symptoms of psychological distress and impaired functioning among patients supported through such programmes. Material and Methods: Between January and December 2019, 5,527 victims of violence received mental health and psychosocial support in 29 health facilities in Burundi, Central African Republic, Democratic Republic of the Congo, Mali, Nigeria and South Sudan. Symptoms of psychological distress (IES-R or DASS21) and daily functioning (ICRC scale) were assessed before and after the intervention. Logistical regression models were used to measure associations between these symptoms and the other variables. Results: Factors associated with high distress prior to receiving support included age (peaking at 45-54 years), intervening within three months, rape, caretaker neglect, internal displacement, secondary education level and referral pathway. Anxiety levels in particular were higher among victims of violence committed by unknown civilians, the military or armed groups. Low functioning was associated with divorce, grief and violence committed by the military or armed groups. Following the intervention, the vast majority of patients reported reduced psychological distress (97.25% for IES-R and 99.11% for DASS21) and improved daily functioning (93.58%). A linear trend was found between number of individual sessions and reduction in symptoms of distress. Financial losses were associated with less reduction in symptoms of depression and stress. Discussion: To further address the mental health and psychosocial needs of victims of violence, intervening quickly and increasing the number of individual sessions per patient is crucial. This requires proximity-being in the right place at the right time-which is challenging when working in stable health structures. Symptoms of depression should not be overlooked, and financial losses must be addressed in order to holistically meet the needs of victims of violence.

Cognitive behavioral psychotherapeutic treatment at a psychiatric trauma clinic for refugees: description and evaluation.

INTRODUCTION: Cognitive behavioural therapy (CBT) with trauma focus is the most evidence supported psychotherapeutic treatment of PTSD, but few CBT treatments for traumatized refugees have been described in detail. PURPOSE: To describe and evaluate a manualized cognitive behavioral therapy for traumatized refugees incorporating exposure therapy, mindfulness and acceptance and commitment therapy. MATERIAL AND METHODS: 85 patients received six months' treatment at a Copenhagen Trauma Clinic for Refugees and completed self-ratings before and after treatment. The treatment administered to each patient was monitored in detail. The changes in mental state and the treatment components associated with change in state were analyzed statistically. RESULTS: Despite the low level of functioning and high co-morbidity of patients, 42% received highly structured CBT, which was positively associated with all treatment outcomes. The more methods used and the more time each method was used, the better the outcome. The majority of patients were able to make homework assignments and this was associated with better treatment outcome. Correlation analysis showed no association between severity of symptoms at baseline and the observed change. CONCLUSION: The study suggests that CBT treatment incorporating mindfulness and acceptance and commitment therapy is promising for traumatized refugees and punctures the myth that this group of patients are unable to participate fully in structured CBT. However, treatment methods must be adapted to the special needs of refugees and trauma exposure should be further investigated.