Neurofeedback for Post-Traumatic Stress Disorder

Study Overview
=================
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. TAU + Neurofeedback using a PC-screen (experimental group) 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.

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

Conditions
-----------------
Post-traumatic Stress Disorder

Intervention / Treatment
-----------------
* Device: Neurofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Allocation is to one of two arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurofeedback<br>24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol. | Device: Neurofeedback<br>* A device that assists in training patients in relaxing.<br>* Other names: Biofeedback;|
| No Intervention: Waiting list<br>Those assigned to waiting list will be able to pick one of the two interventions at the end of the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) | 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) | 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) | 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) | 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) | 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) | 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) | A cognitive test measuring attention, vigilance and memory. | Through study completion, an average of 3 months | 
| Wisconsin Card Sorting Test (WCST) | A cognitive test measuring attention, vigilance and memory. | 4 weeks after finished intervention, an average of 4 months | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neurofeedback, Electroencephalogram (EEG)