Neurofeedback for Post-Traumatic Stress Disorder (ViN-PTSD)

April 11, 2023 updated by: Steinn Steingrimsson

Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.

A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized-controlled pilot and in a later study virtual reality based neurofeedback will be tested. In this study 30 subjects will be randomised into one of two arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.

  1. TAU + Neurofeedback using a PC-screen (experimental group)
  2. 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 30 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 experimental group 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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: Neurofeedback
24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.
Device: Neurofeedback
A device that assists in training patients in relaxing.
Other Names:
  • Biofeedback
  • EEG assisted neurofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician Administered PTSD Scale (CAPS)
Time Frame: Through study completion, an average of 3 months
An interview based scale of symptoms of PTSD
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Event Scale - Revised (IES-R)
Time Frame: 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.
Through study completion, an average of 3 months
Impact of Event Scale - Revised (IES-R)
Time Frame: 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.
4 weeks after finished intervention for the two intervention arms.
Visual Analogue Scale for Wellbeing (VAS-W)
Time Frame: 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".
Before and after each session 1-24 for the two intervention arms.
Insomnia Severity Index (ISI)
Time Frame: 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.
Through study completion, an average of 3 months
Insomnia Severity Index (ISI)
Time Frame: 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.
4 weeks after finished intervention for the two intervention arms.
Wisconsin Card Sorting Test (WCST)
Time Frame: Through study completion, an average of 3 months
A cognitive test measuring attention, vigilance and memory.
Through study completion, an average of 3 months
Wisconsin Card Sorting Test (WCST)
Time Frame: 4 weeks after finished intervention, an average of 4 months
A cognitive test measuring attention, vigilance and memory.
4 weeks after finished intervention, an average of 4 months
Clinician Administered PTSD Scale (CAPS)
Time Frame: For those that have finished the intervention CAPS at one month post treatment
An interview based scale of symptoms of PTSD
For those that have finished the intervention CAPS at one month post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steinn Steingrimsson

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUNF001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This will be discussed if the occasion arises in order to follow GDPR and ethical rules.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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