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Clinical Trials/NCT05055037
NCT05055037
Completed
Not Applicable

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

Mental Health Services in the Capital Region, Denmark1 site in 1 country32 target enrollmentNovember 22, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
32
Locations
1
Primary Endpoint
Harvard Trauma Questionnaire (HTQ)
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2018
End Date
March 13, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Harvard Trauma Questionnaire (HTQ)

Time Frame: Baseline and after 12 weeks

Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire

Secondary Outcomes

  • WHO-Five Well-being Index (WHO-5)(Baseline and after 12 weeks)
  • Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A)(Baseline and after 12 weeks)
  • Hopkins Symptom Checklist-25 (HSCL-25)(Baseline and after 12 weeks)
  • Sheehan Disability Scale (SDS)(Baseline and after 12 weeks)
  • Satisfaction and Accept-ability Questionnaire (SAQ)(After 12 weeks)

Study Sites (1)

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