Neurofeedback as a Treatment for Trauma-affected Refugees

NCT05055037 | Completed DMC

• 1 other identifier: NF
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Neurofeedback; Refugee; Trauma; Qualitative study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hopkins Symptom Checklist-25 (HSCL-25)

  Baseline and after 12 weeks

• Sheehan Disability Scale (SDS)

  Baseline and after 12 weeks

• WHO-Five Well-being Index (WHO-5)

  Baseline and after 12 weeks

• Hamilton interview-based rating scales for depression (Ham-D) and anxiety (Ham-A)

  Baseline and after 12 weeks

• Satisfaction and Accept-ability Questionnaire (SAQ)

  After 12 weeks

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• Lundbeck Foundation: collaborator
• Jascha Fonden: collaborator

Study Sites (1)

Competence Centre for Transcultural Psychiatry

Ballerup Municipality, 2750, Denmark

Location

Related Publications (1)

• 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.

  PMID: 37755151 DERIVED

Related Links

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

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Sigrid Z Hannemose, MD

  Competence Centre for Transcultural Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: September 23, 2021
• Study Start: November 22, 2018
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: September 23, 2021

Record last verified: 2021-07

Locations

DK (1)