Train Your Brain: Neurofeedback Intervention for PTSD

NCT03858933 | Terminated

• 1 other identifier: UP-16-00399-AM011
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

PTSD; Post-Traumatic Stress Disorder; Acute Stress Syndrome; Emotion Regulation; Depression; Anxiety; Sexual Assault; Combat PTSD

Outcome Measures

Primary Outcomes (1)

• 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. 1. Mild / subthreshold: 2. Moderate / threshold: 3. Severe / markedly elevated: 4. 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.

  administered at Initial Appointment (Week 0) and one week after the 15th neurofeedback session (approximately Week 22).

Secondary Outcomes (6)

• Emotion Regulation Questionnaire

  administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)

• Beck Depression Inventory

  administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)

• Beck Anxiety Inventory

  administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)

• PTSD Checklist for DSM-5

  administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)

• Sleep Duration

  administered at Initial Appointment (Week 0), Start of Neurofeedback (Week 7) and one week after the 15th neurofeedback session (approximately Week 22)

Study Arms (2)

Limbic Modulation Index Neurofeedback

EXPERIMENTAL

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.

Device: eBrainFit Platform

Alpha/Theta Neurofeedback

ACTIVE COMPARATOR

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.

Device: eBrainFit Platform

Interventions

eBrainFit Platform DEVICE

Alpha/Theta regulation with eyes open

Alpha/Theta Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• Tel Aviv University: collaborator

Study Sites (1)

University Of Southern California

Los Angeles, California, 90089, United States

Location

Related Links

• Online Eligibility Survey

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emotional Regulation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior; Behavioral Symptoms

Study Officials

• Jeremy Goldbach, PhD

  Faculty Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: March 1, 2019
• Study Start: April 19, 2018
• Primary Completion: March 14, 2020
• Study Completion: December 31, 2020
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

US (1)