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

Steinn Steingrimsson

Status: Enrolling

Conditions: Post-traumatic Stress Disorder

Treatments: Device: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05123690

SUNF001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Neurofeedback

Experimental group

Description:

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

Treatment:

Device: Neurofeedback

Waiting list

No Intervention group

Description:

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