Neurofeedback as a Treatment for Trauma-affected Refugees

Study Overview
=================
Brief Summary
-----------------
Neurofeedback (NF) is a form of treatment that can assist individuals in learning to control their brain wave activity. NF-studies have shown promising results in reducing PSTD-symptoms among military veterans, but there are no published peer-reviewed studies with refugees. However, preliminary studies from Malmö and Sydney indicate that refugees could benefit from NF. Therefore, at the Competence Centre for Transcultural Psychiatry (CTP) a longitudinal feasibility study, testing NF for trauma-affected was started. The study contains both a quantitative and a qualitative substudy. In in the quantitative substudy, where a total of 32 participants have been included, the aim was to evaluate the feasibility of NF with trauma affected refugees using a quantitative perspective. The NF intervention offered was 12 training sessions of 12-20 minutes NF, and the outcome measures were self-administered questionnaires and semi-structured interviews collected before and after the intervention. In a subsample of eight participants of those included in the quantitative substudy, qualitative in-depth interviews were carried out. The participants were offered two interviews; one before the first NF training and one during the treatment course. The aim of the qualitative substudy was to evaluate the feasibility of NF with trauma-affected refugees by examining the participants' thoughts and expectations prior to participating in NF treatment as well as their experience with the treatment after a few sessions.

Official Title
-----------------
Exploring the Feasibility of Neurofeedback for Trauma-affected Refugees - a Qualitative Study

Conditions
-----------------
Post Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Other: Neurofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refugee or a person who had been family reunified with a refugee Diagnosed with PTSD (ICD-10 diagnosis F43.1) and experienced a psychological trauma in another country than Denmark. Informed consent. Exclusion Criteria: Current abuse of drug or alcohol (F1x.24-F1x.26) Diagnosed with a severe psychotic disorder (F2x) or a manic disorder (F30.1-F31.9). No informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Neurofeedback|In neurofeedback (NF), the brainwave activity is measured by an electro-encephalography and fed back to the person as an auditory or visual signal, rewarding the person each time progress is made toward normalizing dysregulated neural activity. The learning mechanism is at its base considered to be operant conditioning, where the behavior of the participant-in this case, neurological activity-is gradually changed through repeated reinforcement. In neurofeedback, this simple learning mechanism is accelerated by continuous and instant feedback, with rewards occurring as often as every second. The NF intervention included 12 NF training sessions, one session per week, off approximately 12-20 min. The protocol was a replicate of the setup of recent NF studies investigating NF as a treatment for chronic PTSD. The feedback was based on a single channel recording, rewarding brainwave frequencies associated with a calm and relaxed state and inhibiting drowsiness and hyperarousal.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harvard Trauma Questionnaire (HTQ) | Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire | Baseline and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopkins Symptom Checklist-25 (HSCL-25) | Change in depressive and anxiety symptoms | Baseline and after 12 weeks | 
| Sheehan Disability Scale (SDS) | Changes in functioning | Baseline and after 12 weeks | 
| WHO-Five Well-being Index (WHO-5) | Change in quality of life | Baseline and after 12 weeks | 
| Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A) | Change in depressive and anxiety symptoms | Baseline and after 12 weeks | 
| Satisfaction and Accept-ability Questionnaire (SAQ) | Evaluation of the the patients' satisfaction and potential discomfort. | After 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurofeedback, Refugee, Trauma, Qualitative study