Neurofeedback as a Treatment for Trauma-affected Refugees

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder

• Registration Number: NCT05055037
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-22
• Primary Completion: 2020-03-13
• Study Completion: 2020-03-13
• Status Verified: 2021-07
• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-23
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Harvard Trauma Questionnaire (HTQ)	Baseline and after 12 weeks	Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Competence Centre for Transcultural Psychiatry; 🇩🇰 Ballerup, Denmark