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Train Your Brain: Neurofeedback Intervention for PTSD

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eBrainFit Platform
eBrainFit Platform
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Post-Traumatic Stress Disorder, Acute Stress Syndrome, Emotion Regulation, Depression, Anxiety, Sexual Assault, Combat PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previous diagnosis of PTSD
  • PTSD symptoms within the last 30 days

Exclusion Criteria:

  • Any active psychosis or suicidal intent
  • A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours)
  • Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.

Sites / Locations

  • University Of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Limbic Modulation Index Neurofeedback

Alpha/Theta Neurofeedback

Arm Description

This arm of the study will undergo a novel neurofeedback treatment, targeting downregulation of deep limbic structures, specifically the amygdalae. Participants in this arm will complete 15 neurofeedback sessions.

This arm of the study will undergo a proven PTSD neurofeedback treatment, alpha/theta regulation, during which participants will try various mental strategies to increase the presence of theta waves. Participants in this arm will complete 15 neurofeedback sessions.

Outcomes

Primary Outcome Measures

Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
The five-point CAPS-5 symptom severity rating scale is used for all symptoms. Rating scale anchors should be interpreted and used as follows: 0 Absent The respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion. Mild / subthreshold: Moderate / threshold: Severe / markedly elevated: Extreme / incapacitating: CAPS-5 total symptom severity score is calculated by summing severity scores for items 1-20. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms contained in a given DSM-5 cluster.

Secondary Outcome Measures

Emotion Regulation Questionnaire
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet. Items 2, 4, 6, 9 make up the Expressive Suppression facet. Scoring is kept continuous. Each facet's scoring is kept separate.
Beck Depression Inventory
Quantifies depressive symptoms using a 21-item measure. Depression severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Beck Anxiety Inventory
Quantifies anxious symptoms using a 21-item measure Anxiety severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
PTSD Checklist for DSM-5
Quantifies PTSD symptoms using a 20-item measure PTSD severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Sleep Duration
Captured using a Fitbit Physical Activity Tracking Device The device will report the participant's sleep duration (output in minutes) for each night the device is worn.
Emotional Stroop Task
Behavioral metric of conflict adaptation. Emotion regulation will be assessed using a well-established emotional conflict paradigm that arises from an incompatibility between the task-relevant and task-irrelevant emotional dimensions of a stimulus and allows for the tracking of emotion regulation from trial to trial. In this task there is less conflict, indexed by faster reaction times for incongruent trials, than if they are preceded by a congruent trial. This difference in reaction times between low conflict resolution and high conflict resolution trials serves as a behavioral metric of conflict adaptation. A negative adaptation score reflects activation of a regulatory mechanism that leads to improved emotional conflict resolution.

Full Information

First Posted
November 16, 2018
Last Updated
August 23, 2021
Sponsor
University of Southern California
Collaborators
Tel Aviv University
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1. Study Identification

Unique Protocol Identification Number
NCT03858933
Brief Title
Train Your Brain: Neurofeedback Intervention for PTSD
Official Title
Train Your Brain: A Neurofeedback Intervention for Individuals With Post-Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 Regulations
Study Start Date
April 19, 2018 (Actual)
Primary Completion Date
March 14, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Tel Aviv University

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
The investigator's aim is to evaluate the efficacy of two types of neurofeedback treatments for PTSD symptoms reduction. Half of the participants will receive the current standard for PTSD neurofeedback care undergoing alpha/theta neurofeedback regulation. The other half will receive the newly developed limbic modulation index neurofeedback.
Detailed Description
Traumatic stress is commonly resistant to existing therapeutics, possibly due to high treatment dropout rates along with a failure to target the relevant underlying neural mechanisms. Neuromodulation of deep limbic areas such as the amygdala may play a critical role in the effective recovery from traumatic stress. Human studies have shown the importance of such modulation during the encoding of traumatic stimuli, showing greater amygdala activation for subsequently remembered traumatic stimuli. In addition, a prospective study among previously healthy soldiers showed that hyper-activation of the amygdala prior to military traumatic exposure corresponded with more severe post-traumatic symptoms following exposure. Together these finding points to the amygdala as a plausible neuromodulation target for preventive or early interventions of post-traumatic disturbances. Local neuromodulation of the amygdala could improve treatment specificity and the overall intervention outcome. The main goal of the suggested research is to further develop and implement a non-invasive, portable and cost-effective brain-imaging tool that will provide individual on-line guidance for amygdala modulation. This closed-loop brain training will enhance individual resilience to and coping with potentially traumatic stress as well as alleviate consequential psychopathologies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Post-Traumatic Stress Disorder, Acute Stress Syndrome, Emotion Regulation, Depression, Anxiety, Sexual Assault, Combat PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The eBrainFit Platform is set to randomize each entered Subject Identification Number into either the alpha/theta or limbic modulation treatment arms. Neither the participant nor researcher will know the arm, to which the participant has been assigned.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Limbic Modulation Index Neurofeedback
Arm Type
Experimental
Arm Description
This arm of the study will undergo a novel neurofeedback treatment, targeting downregulation of deep limbic structures, specifically the amygdalae. Participants in this arm will complete 15 neurofeedback sessions.
Arm Title
Alpha/Theta Neurofeedback
Arm Type
Active Comparator
Arm Description
This arm of the study will undergo a proven PTSD neurofeedback treatment, alpha/theta regulation, during which participants will try various mental strategies to increase the presence of theta waves. Participants in this arm will complete 15 neurofeedback sessions.
Intervention Type
Device
Intervention Name(s)
eBrainFit Platform
Intervention Description
Alpha/Theta regulation with eyes open
Intervention Type
Device
Intervention Name(s)
eBrainFit Platform
Intervention Description
Amygdala regulation with eyes open
Primary Outcome Measure Information:
Title
Change from baseline PTSD severity using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-5
Description
The five-point CAPS-5 symptom severity rating scale is used for all symptoms. Rating scale anchors should be interpreted and used as follows: 0 Absent The respondent denied the problem or the respondent's report doesn't fit the DSM-5 symptom criterion. Mild / subthreshold: Moderate / threshold: Severe / markedly elevated: Extreme / incapacitating: CAPS-5 total symptom severity score is calculated by summing severity scores for items 1-20. CAPS-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms contained in a given DSM-5 cluster.
Time Frame
administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).
Secondary Outcome Measure Information:
Title
Emotion Regulation Questionnaire
Description
A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). Items 1, 3, 5, 7, 8, 10 make up the Cognitive Reappraisal facet. Items 2, 4, 6, 9 make up the Expressive Suppression facet. Scoring is kept continuous. Each facet's scoring is kept separate.
Time Frame
administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Title
Beck Depression Inventory
Description
Quantifies depressive symptoms using a 21-item measure. Depression severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Time Frame
administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Title
Beck Anxiety Inventory
Description
Quantifies anxious symptoms using a 21-item measure Anxiety severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Time Frame
administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Title
PTSD Checklist for DSM-5
Description
Quantifies PTSD symptoms using a 20-item measure PTSD severity is calculated by summing the score responses, with higher values indicating more severe symptom expression.
Time Frame
administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Title
Sleep Duration
Description
Captured using a Fitbit Physical Activity Tracking Device The device will report the participant's sleep duration (output in minutes) for each night the device is worn.
Time Frame
administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)
Title
Emotional Stroop Task
Description
Behavioral metric of conflict adaptation. Emotion regulation will be assessed using a well-established emotional conflict paradigm that arises from an incompatibility between the task-relevant and task-irrelevant emotional dimensions of a stimulus and allows for the tracking of emotion regulation from trial to trial. In this task there is less conflict, indexed by faster reaction times for incongruent trials, than if they are preceded by a congruent trial. This difference in reaction times between low conflict resolution and high conflict resolution trials serves as a behavioral metric of conflict adaptation. A negative adaptation score reflects activation of a regulatory mechanism that leads to improved emotional conflict resolution.
Time Frame
administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previous diagnosis of PTSD PTSD symptoms within the last 30 days Exclusion Criteria: Any active psychosis or suicidal intent A severe traumatic brain injury (one in which consciousness was lost for greater than 6 hours) Any of the following neurological disorders: Parkinson's, Alzheimer's, Brain Tumor, or Brain Lesion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Goldbach, PhD
Organizational Affiliation
Faculty Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://uscsocialwork.qualtrics.com/jfe/form/SV_2b397uP7BK75yUR
Description
Online Eligibility Survey

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Train Your Brain: Neurofeedback Intervention for PTSD

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