Neurofeedback as a Treatment for Trauma-affected Refugees

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055037
• Other study ID #: NF
• Status: Completed
• Phase: N/A
• Start date: November 22, 2018
• Est. completion date: March 13, 2020

Study information

• Verified date: July 2021
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Competence Centre for Transcultural Psychiatry	Ballerup

Sponsors (3)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Jascha Fonden, Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harvard Trauma Questionnaire (HTQ)	Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire	Baseline and after 12 weeks
Secondary	Hopkins Symptom Checklist-25 (HSCL-25)	Change in depressive and anxiety symptoms	Baseline and after 12 weeks
Secondary	Sheehan Disability Scale (SDS)	Changes in functioning	Baseline and after 12 weeks
Secondary	WHO-Five Well-being Index (WHO-5)	Change in quality of life	Baseline and after 12 weeks
Secondary	Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A)	Change in depressive and anxiety symptoms	Baseline and after 12 weeks
Secondary	Satisfaction and Accept-ability Questionnaire (SAQ)	Evaluation of the the patients' satisfaction and potential discomfort.	After 12 weeks

External Links

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