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Neurofeedback as a Treatment for Trauma-affected Refugees

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
Mental Health Services in the Capital Region, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Post Traumatic Stress Disorder focused on measuring Neurofeedback, Refugee, Trauma, Qualitative study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Competence Centre for Transcultural Psychiatry

Outcomes

Primary Outcome Measures

Harvard Trauma Questionnaire (HTQ)
Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2021
Last Updated
September 14, 2021
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Lundbeck Foundation, Jascha Fonden
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1. Study Identification

Unique Protocol Identification Number
NCT05055037
Brief Title
Neurofeedback as a Treatment for Trauma-affected Refugees
Official Title
Exploring the Feasibility of Neurofeedback for Trauma-affected Refugees - a Qualitative Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
Lundbeck Foundation, Jascha Fonden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Neurofeedback, Refugee, Trauma, Qualitative study

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigrid Z Hannemose, MD
Organizational Affiliation
Competence Centre for Transcultural Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Competence Centre for Transcultural Psychiatry
City
Ballerup
ZIP/Postal Code
2750
Country
Denmark

12. IPD Sharing Statement

Links:
URL
https://www.psykiatri-regionh.dk/centre-og-social-tilbud/kompetencecentre/transkulturel-psykiatri/Sider/default.aspx
Description
Description Link to web page of the Competence Centre for Transcultural Psychiatry (mostly in Danish)

Learn more about this trial

Neurofeedback as a Treatment for Trauma-affected Refugees

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