Post-traumatic Stress DisorderViN-PTSDNCT05123690
Neurofeedback for Post-Traumatic Stress Disorder
A study testing Neurofeedback in people with Post-traumatic Stress Disorder, run by Steinn Steingrimsson at 1 site in Sweden.
Trial summary
A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götaland County
Steinn Steingrimsson, MD, PhD, steinn.steingrimsson@vgregion.se
About this study
Official title: Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.
A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.
Read the 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.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Neurofeedback
- Keywords
- Neurofeedback, Electroencephalogram (EEG)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackDevice
Also called EEG assisted neurofeedback, Biofeedback
A device that assists in training patients in relaxing.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | 24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol. Receives: Device: Neurofeedback |
| Waiting list | No intervention | Those assigned to waiting list will be able to pick one of the two interventions at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale (CAPS)
An interview based scale of symptoms of PTSD
Measured: Through study completion, an average of 3 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 4 weeks after finished intervention for the two intervention arms.
Wisconsin Card Sorting Test (WCST)
A cognitive test measuring attention, vigilance and memory.
Measured: Through study completion, an average of 3 months
Wisconsin Card Sorting Test (WCST)
A cognitive test measuring attention, vigilance and memory.
Measured: 4 weeks after finished intervention, an average of 4 months
Clinician Administered PTSD Scale (CAPS)
An interview based scale of symptoms of PTSD
Measured: For those that have finished the intervention CAPS at one month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation is to one of two arms
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steinn Steingrimsson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steinn Steingrimsson, Sahlgrenska University Hospital
- Investigators
- Steinn Steingrimsson, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123690
- Sponsor's protocol ID
- SUNF001
- Acronym
- ViN-PTSD
- Status last verified
- Apr 2023
- First submitted
- 20 Sep 2021
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be discussed if the occasion arises in order to follow GDPR and ethical rules.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.
- ClinicalTrials.gov ID
- NCT05123690
- Acronym / sponsor ID
- ViN-PTSD / SUNF001
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Neurofeedback, Electroencephalogram (EEG)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Steinn SteingrimssonUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation is to one of two arms
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Device: Neurofeedback24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol. |
| Waiting list | No intervention | –Those assigned to waiting list will be able to pick one of the two interventions at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurofeedbackAlso: EEG assisted neurofeedback, BiofeedbackA device that assists in training patients in relaxing. | Device | Neurofeedback |
Primary outcome
Clinician Administered PTSD Scale (CAPS)
Time frame: Through study completion, an average of 3 months
An interview based scale of symptoms of PTSD
8 secondary outcomes
Impact of Event Scale - Revised (IES-R)
Time frame: Through study completion, an average of 3 months
Impact of Event Scale - Revised (IES-R)
Time frame: 4 weeks after finished intervention for the two intervention arms.
Visual Analogue Scale for Wellbeing (VAS-W)
Time frame: Before and after each session 1-24 for the two intervention arms.
Insomnia Severity Index (ISI)
Time frame: Through study completion, an average of 3 months
Insomnia Severity Index (ISI)
Time frame: 4 weeks after finished intervention for the two intervention arms.
Wisconsin Card Sorting Test (WCST)
Time frame: Through study completion, an average of 3 months
Wisconsin Card Sorting Test (WCST)
Time frame: 4 weeks after finished intervention, an average of 4 months
Clinician Administered PTSD Scale (CAPS)
Time frame: For those that have finished the intervention CAPS at one month post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No. This will be discussed if the occasion arises in order to follow GDPR and ethical rules.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steinn Steingrimsson, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Post-traumatic Stress Disorder, run by Steinn Steingrimsson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steinn Steingrimsson, PhD (0046313421000, steinn.steingrimsson@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (CAPS) (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.