Neurofeedback for Post-Traumatic Stress Disorder

Post-traumatic Stress Disorder Clinical Trial

— ViN-PTSD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05123690
• Other study ID #: SUNF001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Steinn Steingrimsson, PhD
• Phone: 0046313421000
• Email: steinn.steingrimsson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• Neurofeedback
A device that assists in training patients in relaxing.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Steinn Steingrimsson

Country where clinical trial is conducted

Sweden, 

Outcome

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