An interventional study of Neurofeedback in Post-traumatic Stress Disorder, sponsored by Steinn Steingrimsson. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.
Sponsored by Steinn Steingrimsson · Not applicable, Interventional, and Treatment
A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.
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.
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →This is the only study on the registry with Steinn Steingrimsson as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.
Device: Neurofeedback
Those assigned to waiting list will be able to pick one of the two interventions at the end of the study.
A device that assists in training patients in relaxing.
Also known as: EEG assisted neurofeedback, Biofeedback
Clinician Administered PTSD Scale (CAPS)
An interview based scale of symptoms of PTSD
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 4 weeks after finished intervention for the two intervention arms.
Wisconsin Card Sorting Test (WCST)
A cognitive test measuring attention, vigilance and memory.
Time frame: Through study completion, an average of 3 months
Wisconsin Card Sorting Test (WCST)
A cognitive test measuring attention, vigilance and memory.
Time frame: 4 weeks after finished intervention, an average of 4 months
Clinician Administered PTSD Scale (CAPS)
An interview based scale of symptoms of PTSD
Time frame: For those that have finished the intervention CAPS at one month post treatment
Plan to share: No — This will be discussed if the occasion arises in order to follow GDPR and ethical rules.
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