Neurofeedback as a Treatment for Trauma-affected Refugees

September 14, 2021 updated by: Mental Health Services in the Capital Region, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Ballerup, Denmark, 2750
        • Competence Centre for Transcultural Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and after 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mental Health Services in the Capital Region, Denmark

Collaborators

Lundbeck Foundation
Jascha Fonden

Investigators

  • Principal Investigator: Sigrid Z Hannemose, MD, Competence Centre for Transcultural Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 22, 2018

Primary Completion (ACTUAL)

March 13, 2020

Study Completion (ACTUAL)

March 13, 2020

Study Registration Dates

First Submitted

July 26, 2021

First Submitted That Met QC Criteria

September 14, 2021

First Posted (ACTUAL)

September 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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