Post Traumatic Stress DisorderNCT05055037
Neurofeedback as a Treatment for Trauma-affected Refugees
A study testing Neurofeedback in people with Post Traumatic Stress Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Neurofeedback
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Nov 2018to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Competence Centre for Transcultural Psychiatry
Ballerup Municipality, 2750
About this study
Official title: 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Neurofeedback
- Keywords
- Neurofeedback, Refugee, Trauma, Qualitative study
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvard Trauma Questionnaire (HTQ)
Change in PTSD symptoms measured by the first 16 items in the Harvard Trauma Questionnaire
Measured: Baseline and after 12 weeks
Secondary outcomes (5)
Hopkins Symptom Checklist-25 (HSCL-25)
Change in depressive and anxiety symptoms
Measured: Baseline and after 12 weeks
Sheehan Disability Scale (SDS)
Changes in functioning
Measured: Baseline and after 12 weeks
WHO-Five Well-being Index (WHO-5)
Change in quality of life
Measured: Baseline and after 12 weeks
Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A)
Change in depressive and anxiety symptoms
Measured: Baseline and after 12 weeks
Satisfaction and Accept-ability Questionnaire (SAQ)
Evaluation of the the patients' satisfaction and potential discomfort.
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start22 Nov 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Jascha Fonden
- Responsible party
- Sponsor
- Investigators
- Sigrid Z Hannemose, MD, Principal investigator, Competence Centre for Transcultural Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055037
- Sponsor's protocol ID
- NF
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37755151
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Neurofeedback for Trauma-affected Refugees - a Qualitative Study
- ClinicalTrials.gov ID
- NCT05055037
- Acronym / sponsor ID
- NF
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Neurofeedback, Refugee, Trauma, Qualitative study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg HospitalUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Jascha Fonden
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackIn 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. | Other | – |
Primary outcome
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
5 secondary outcomes
Hopkins Symptom Checklist-25 (HSCL-25)
Time frame: Baseline and after 12 weeks
Sheehan Disability Scale (SDS)
Time frame: Baseline and after 12 weeks
WHO-Five Well-being Index (WHO-5)
Time frame: 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
Satisfaction and Accept-ability Questionnaire (SAQ)
Time frame: After 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 37755151Hannemose 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.
- Description Link to web page of the Competence Centre for Transcultural Psychiatry (mostly in Danish)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigrid Z Hannemose, MD principal investigator
Competence Centre for Transcultural Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Post Traumatic Stress Disorder, run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard Trauma Questionnaire (HTQ) (time frame: Baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055037, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.