ViN-PTSD: Virtual Neurofeedback for Post-Traumatic Stress Disorder
Study Details
Study Description
Brief Summary
A three-arm randomized trial of standard neurofeedback, virtual-reality based neurofeedback and a waiting list for patientes with treatment resistent PTSD.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
This study will be a randomized-controlled trial. In this study 45 subjects will be randomised into one of three arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.
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TAU + Neurofeedback using virtual-reality (VR) (experimental group)
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TAU + Neurofeedback using a PC-screen (experimental group)
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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 45 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 two experimental groups 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Neurofeedback 24 sessions of ca 45 minutes neurofeedback using a alpha-theta protocol, twice weekly. |
Device: Neurofeedback
A device that assists in training patients in relaxing.
Other Names:
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Experimental: Virtual reality assisted neurofeedback 24 sessions of ca 45 minutes neurofeedback using a headset that has sensors over the frontal cortex Fp1 and Fp2. The neurofeedback uses a high-beta down protocol and is administered twice weekly. |
Device: Neurofeedback
A device that assists in training patients in relaxing.
Other Names:
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No Intervention: Waiting list Those assigned to waiting list will be able to pick one of the two interventions at the end of the study. |
Outcome Measures
Primary Outcome Measures
- Clinician Administered PTSD Scale (CAPS) [Through study completion, an average of 3 months]
An interview based scale of symptoms of PTSD
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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.
- Wisconsin Card Sorting Test (WCST) [Through study completion, an average of 3 months]
A cognitive test measuring attention, vigilance and memory.
- Wisconsin Card Sorting Test (WCST) [4 weeks after finished intervention, an average of 4 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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CAPS Cutoff >44
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Stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial)
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AUDIT cut off <16
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DUDIT cut off <8
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Already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months.
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18 years or older
Exclusion Criteria:
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Diagnosis of traumatic brain injury (TBI) affecting capability to give informed consent
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Ongoing traumatic exposure (such as domestic violence)
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Balance problems
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Active suicide risk or life-threatening self-harm
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A diagnosis of schizophrenia or psychotic disorder
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Ongoing compulsory care
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If the patient changes dose or medication strategy during the trial.
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If the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Steinn Steingrimsson
Investigators
- Principal Investigator: Steinn Steingrimsson, PhD, Sahlgrenska University Hospital, Sweden
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SUNF001