Neurofeedback for Post-Traumatic Stress Disorder

NCT05123690 | Unknown

• 1 other identifier: SUNF001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-traumatic Stress Disorder

Keywords

Neurofeedback; Electroencephalogram (EEG)

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS)

  An interview based scale of symptoms of PTSD

  Through study completion, an average of 3 months

Secondary Outcomes (8)

• Impact of Event Scale - Revised (IES-R)

  Through study completion, an average of 3 months

• Impact of Event Scale - Revised (IES-R)

  4 weeks after finished intervention for the two intervention arms.

• Visual Analogue Scale for Wellbeing (VAS-W)

  Before and after each session 1-24 for the two intervention arms.

• Insomnia Severity Index (ISI)

  Through study completion, an average of 3 months

• Insomnia Severity Index (ISI)

  4 weeks after finished intervention for the two intervention arms.

Study Arms (2)

Neurofeedback

EXPERIMENTAL

24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.

Device: Neurofeedback

Waiting list

NO INTERVENTION

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

Interventions

Neurofeedback DEVICE

A device that assists in training patients in relaxing.

Also known as: EEG assisted neurofeedback, Biofeedback

Neurofeedback

Eligibility Criteria

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

You may qualify if:

• 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.
• years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steinn Steingrimsson: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Neurofeedback; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Steinn Steingrimsson, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steinn Steingrimsson, PhD

CONTACT

0046313421000; steinn.steingrimsson@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Statistical analysis will be done seperately
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator & clinical associate professor

Model Details: Allocation is to one of two arms

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: November 17, 2021
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)