Neurofeedback as a Treatment for Trauma-affected Refugees

NCT ID: NCT05055037

Last Updated: 2021-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2020-03-13

Brief Summary

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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

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Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

Jascha Fonden

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sigrid Z Hannemose, MD

Role: PRINCIPAL_INVESTIGATOR

Competence Centre for Transcultural Psychiatry

Locations

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Competence Centre for Transcultural Psychiatry

Ballerup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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Hannemose SZ, Laugesen Attardo H, Vindbjerg E, Carlsson J. Exploring expectations of neurofeedback treatment among trauma-affected refugees. Nord J Psychiatry. 2024 Jan;78(1):46-53. doi: 10.1080/08039488.2023.2261905. Epub 2024 Jan 8.

Reference Type DERIVED
PMID: 37755151 (View on PubMed)

Related Links

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https://www.psykiatri-regionh.dk/centre-og-social-tilbud/kompetencecentre/transkulturel-psykiatri/Sider/default.aspx

Description Link to web page of the Competence Centre for Transcultural Psychiatry (mostly in Danish)

Other Identifiers

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NF

Identifier Type: -

Identifier Source: org_study_id

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