Neurofeedback for Post-Traumatic Stress Disorder

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder
• Interventions: Device: Neurofeedback

• Registration Number: NCT05123690
• Lead Sponsor: Steinn Steingrimsson

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-17
• Study Start: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurofeedback	Neurofeedback	24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale (CAPS)	Through study completion, an average of 3 months	An interview based scale of symptoms of PTSD

Secondary Outcome Measures

Name	Time	Method
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.
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
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".
Wisconsin Card Sorting Test (WCST)	4 weeks after finished intervention, an average of 4 months	A cognitive test measuring attention, vigilance and memory.
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.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden