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Completed

NCT Number: NCT05055037

Neurofeedback as a Treatment for Trauma-affected Refugees

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Competence Centre for Transcultural Psychiatry

Ballerup Municipality, 2750, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurofeedback

Other

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.

Primary outcomes

  1. 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

  1. Hopkins Symptom Checklist-25 (HSCL-25)

    Time frame: Baseline and after 12 weeks

    Change in depressive and anxiety symptoms

  2. Sheehan Disability Scale (SDS)

    Time frame: Baseline and after 12 weeks

    Changes in functioning

  3. WHO-Five Well-being Index (WHO-5)

    Time frame: Baseline and after 12 weeks

    Change in quality of life

  4. 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

  5. Satisfaction and Accept-ability Questionnaire (SAQ)

    Time frame: After 12 weeks

    Evaluation of the the patients' satisfaction and potential discomfort.

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • Jascha Fonden
  • Lundbeck Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 23, 2021
Registry last updated
Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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