Post-traumatic Stress Disorder
Conditions
Keywords
Neurofeedback, Electroencephalogram (EEG)
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.
Interventions
DEVICENeurofeedback
A device that assists in training patients in relaxing.
Sponsors
Steinn Steingrimsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Statistical analysis will be done seperately
Intervention model description
Allocation is to one of two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale (CAPS) | Through study completion, an average of 3 months | An interview based scale of symptoms of PTSD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Event Scale - Revised (IES-R) | Through study completion, an average of 3 months | 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. |
| 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. |
| Insomnia Severity Index (ISI) | Through study completion, an average of 3 months | 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. |
| Wisconsin Card Sorting Test (WCST) | Through study completion, an average of 3 months | A cognitive test measuring attention, vigilance and memory. |
| 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 |
Countries
Sweden
Contacts
Primary ContactSteinn Steingrimsson, PhD
Outcome results
None listed