ViN-PTSD: Virtual Neurofeedback for Post-Traumatic Stress Disorder

Sponsor
Steinn Steingrimsson (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05123690
Collaborator
(none)
45
Enrollment
3
Arms
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A three-arm randomized trial of standard neurofeedback, virtual-reality based neurofeedback and a waiting list for patientes with treatment resistent PTSD.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Neurofeedback
N/A

Detailed Description

This study will be a randomized-controlled trial. In this study 45 subjects will be randomised into one of three arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.

  1. TAU + Neurofeedback using virtual-reality (VR) (experimental group)

  2. TAU + Neurofeedback using a PC-screen (experimental group)

  3. TAU as a waiting list (control group) - the participants in the control group will be offered to choose one of the two experimental treatments at the end of the trial.

The 45 participants will be randomized to one arm of the study (15 participants per group). The subjects will be recruited from Psychiatric Outpatient Care at Sahlgrenska University Hospital, Crisis and Trauma Center Gothenburg and Psychiatric Care Center in Tranås, Jönköping.

Participants in the two experimental groups will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. Before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Allocation is to one of three armsAllocation is to one of three arms
Masking:
Single (Outcomes Assessor)
Masking Description:
Statistical analysis will be done seperately
Primary Purpose:
Treatment
Official Title:
Virtual Neurofeedback for Post-Traumatic Stress Disorder (ViN-PTSD). A Randomized Trial of Virtual Reality Assisted Neurofeedback and Standard Neurofeedback
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Neurofeedback

24 sessions of ca 45 minutes neurofeedback using a alpha-theta protocol, twice weekly.

Device: Neurofeedback
A device that assists in training patients in relaxing.
Other Names:
  • EEG assisted neurofeedback
  • Biofeedback
  • Experimental: Virtual reality assisted neurofeedback

    24 sessions of ca 45 minutes neurofeedback using a headset that has sensors over the frontal cortex Fp1 and Fp2. The neurofeedback uses a high-beta down protocol and is administered twice weekly.

    Device: Neurofeedback
    A device that assists in training patients in relaxing.
    Other Names:
  • EEG assisted neurofeedback
  • Biofeedback
  • No Intervention: Waiting list

    Those assigned to waiting list will be able to pick one of the two interventions at the end of the study.

    Outcome Measures

    Primary Outcome Measures

    1. Clinician Administered PTSD Scale (CAPS) [Through study completion, an average of 3 months]

      An interview based scale of symptoms of PTSD

    Secondary Outcome Measures

    1. Impact of Event Scale - Revised (IES-R) [Through study completion, an average of 3 months]

      IES-R is a self-assessment scale that measures the degree to which one has been affected by post-traumatic stress reactions during the last 7 days.

    2. Impact of Event Scale - Revised (IES-R) [4 weeks after finished intervention for the two intervention arms.]

      IES-R is a self-assessment scale that measures the degree to which one has been affected by post-traumatic stress reactions during the last 7 days.

    3. Visual Analogue Scale for Wellbeing (VAS-W) [Before and after each session 1-24 for the two intervention arms.]

      The measurement is a 10 point scale ranging from 1-10 with a visual representation (a sad face at 1 and happy face at 10) asking "How are you feeling right now".

    4. Insomnia Severity Index (ISI) [Through study completion, an average of 3 months]

      The scale consists of 7 items where participants can score their sleep quality and frequency on a scale from 0-4. 0 being no problems while 4 meaning significant problems. The score ranges from 0-28.

    5. Insomnia Severity Index (ISI) [4 weeks after finished intervention for the two intervention arms.]

      The scale consists of 7 items where participants can score their sleep quality and frequency on a scale from 0-4. 0 being no problems while 4 meaning significant problems. The score ranges from 0-28.

    6. Wisconsin Card Sorting Test (WCST) [Through study completion, an average of 3 months]

      A cognitive test measuring attention, vigilance and memory.

    7. Wisconsin Card Sorting Test (WCST) [4 weeks after finished intervention, an average of 4 months]

      A cognitive test measuring attention, vigilance and memory.

    8. Clinician Administered PTSD Scale (CAPS) [For those that have finished the intervention CAPS at one month post treatment]

      An interview based scale of symptoms of PTSD

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • CAPS Cutoff >44

    • Stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial)

    • AUDIT cut off <16

    • DUDIT cut off <8

    • Already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months.

    • 18 years or older

    Exclusion Criteria:
    • Diagnosis of traumatic brain injury (TBI) affecting capability to give informed consent

    • Ongoing traumatic exposure (such as domestic violence)

    • Balance problems

    • Active suicide risk or life-threatening self-harm

    • A diagnosis of schizophrenia or psychotic disorder

    • Ongoing compulsory care

    • If the patient changes dose or medication strategy during the trial.

    • If the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Steinn Steingrimsson

    Investigators

    • Principal Investigator: Steinn Steingrimsson, PhD, Sahlgrenska University Hospital, Sweden

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steinn Steingrimsson, Principal investigator & clinical associate professor, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT05123690
    Other Study ID Numbers:
    • SUNF001
    First Posted:
    Nov 17, 2021
    Last Update Posted:
    Nov 17, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Steinn Steingrimsson, Principal investigator & clinical associate professor, Sahlgrenska University Hospital, Sweden
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 17, 2021