Clinical trial NCT05055037: Neurofeedback as a Treatment for Trauma-affected Refugees
Official title: Exploring the Feasibility of Neurofeedback for Trauma-affected Refugees - a Qualitative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Neurofeedback
Refugee
Trauma
Qualitative study
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: Jascha Fonden
First posted: 2021-09-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Harvard Trauma Questionnaire (HTQ)
timeFrame: Baseline and after 12 weeks
Secondary outcomes:
measure: Hopkins Symptom Checklist-25 (HSCL-25)
timeFrame: Baseline and after 12 weeks
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline and after 12 weeks
measure: WHO-Five Well-being Index (WHO-5)
timeFrame: Baseline and after 12 weeks
measure: Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A)
timeFrame: Baseline and after 12 weeks
measure: Satisfaction and Accept-ability Questionnaire (SAQ)
timeFrame: After 12 weeks
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Competence Centre for Transcultural Psychiatry
Study officials:
affiliation: Competence Centre for Transcultural Psychiatry
name: Sigrid Z Hannemose, MD
role: PRINCIPAL_INVESTIGATOR
References: