Neurofeedback for Post-Traumatic Stress Disorder (ViN-PTSD)
Primary Purpose
Post-traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Neurofeedback, Electroencephalogram (EEG)
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.
Sites / Locations
- Sahlgrenska University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Neurofeedback
Waiting list
Arm Description
24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.
Those assigned to waiting list will be able to pick one of the two interventions at the end of the study.
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS)
An interview based scale of symptoms of PTSD
Secondary Outcome Measures
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.
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.
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".
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.
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.
Wisconsin Card Sorting Test (WCST)
A cognitive test measuring attention, vigilance and memory.
Wisconsin Card Sorting Test (WCST)
A cognitive test measuring attention, vigilance and memory.
Clinician Administered PTSD Scale (CAPS)
An interview based scale of symptoms of PTSD
Full Information
NCT ID
NCT05123690
First Posted
September 20, 2021
Last Updated
April 11, 2023
Sponsor
Steinn Steingrimsson
1. Study Identification
Unique Protocol Identification Number
NCT05123690
Brief Title
Neurofeedback for Post-Traumatic Stress Disorder
Acronym
ViN-PTSD
Official Title
Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steinn Steingrimsson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
Neurofeedback, Electroencephalogram (EEG)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Allocation is to one of two arms
Masking
None (Open Label)
Masking Description
Statistical analysis will be done seperately
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
24 sessions of ca 45 minutes neurofeedback using alpha-theta protocol.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Those assigned to waiting list will be able to pick one of the two interventions at the end of the study.
Intervention Type
Device
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
EEG assisted neurofeedback, Biofeedback
Intervention Description
A device that assists in training patients in relaxing.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
An interview based scale of symptoms of PTSD
Time Frame
Through study completion, an average of 3 months
Secondary Outcome Measure Information:
Title
Impact of Event Scale - Revised (IES-R)
Description
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
Title
Impact of Event Scale - Revised (IES-R)
Description
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.
Title
Visual Analogue Scale for Wellbeing (VAS-W)
Description
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.
Title
Insomnia Severity Index (ISI)
Description
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
Title
Insomnia Severity Index (ISI)
Description
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.
Title
Wisconsin Card Sorting Test (WCST)
Description
A cognitive test measuring attention, vigilance and memory.
Time Frame
Through study completion, an average of 3 months
Title
Wisconsin Card Sorting Test (WCST)
Description
A cognitive test measuring attention, vigilance and memory.
Time Frame
4 weeks after finished intervention, an average of 4 months
Title
Clinician Administered PTSD Scale (CAPS)
Description
An interview based scale of symptoms of PTSD
Time Frame
For those that have finished the intervention CAPS at one month post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steinn Steingrimsson, PhD
Phone
0046313421000
Email
steinn.steingrimsson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steinn Steingrimsson, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götaland
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steinn Steingrimsson, MD, PhD
Email
steinn.steingrimsson@vgregion.se
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This will be discussed if the occasion arises in order to follow GDPR and ethical rules.
Learn more about this trial
Neurofeedback for Post-Traumatic Stress Disorder
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