A Neurofeedback Booster for Emotion Regulation Therapy (BrainBoost)

BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy

This is a proof-of-concept study that aims to test the additional value of adjuvant neurofeedback treatment for psychotherapy. Three sessions of real-time fMRI neurofeedback will be administered to N=22 patients with BPD while they receive residential Dialectical Behavior Therapy treatment. In addition, outcomes are assessed from a control group with same sample size who do not receive the treatment.

Study Overview

• Status: Recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Behavioral: Neurofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Paret, Dr. sc. hum.; Phone Number: (+49) 621 - 1703-4462; Email: christian.paret@zi-mannheim.de

Study Locations

• Germany
  • Mannheim, Germany, 68159
    • Recruiting
    • Central Institute of Mental Health
    • Contact: Paret; Phone Number: 4462 +49 621 1703; Email: christian.paret@zi-mannheim.de
    • Sub-Investigator: Miroslava Jindrova, Msc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• DSM-5 BPD diagnosis
• informed consent
• EtOH and tox negative on the day of neurofeedback
• BSL-23 score >=1.87 at DBT halftime

Exclusion Criteria:

• pharmacotherapy with opiates
• standing benzodiazepines (bedtime-only benzodiazepines and anti-histamines allowed)
• pregnancy
• epilepsy
• life-time diagnosis schizophrenia or bipolar disorder I
• significant current or past neurological illness
• BMI<16.5
• usual safety criteria for magnetic resonance imaging

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Treatment	Behavioral: Neurofeedback; fMRI neurofeedback training of amygdala downregulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in affective instability	Mean successive squared differences (MSSD) of six-item negative affect scale measured via behavioural sampling using ecological momentary assessment (EMA) over four days. MSSD will be compared between baseline and post-treatment timepoints.	Before treatment, immediately after treatment + follow-up measure (3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotion regulation	Negative and neutral pictures are either presented with instruction to regulate or to respond naturally (view). BOLD response in the amygdala (and the rest of the brain) is measured and subjective ratings of regulation success are collected. Changes (between the time points) in differences of the two conditions (regulate vs. view) are measured for both: amygdala BOLD response and subjective ratings of regulation success.	Before treatment, immediately after treatment + follow-up measure (3 months)
Change in borderline symptomatology	Facets of BPD are assessed with questionnaires, including impulsivity. Borderline Symptom List (BSL-23) score will be used for assesment of BPD symptoms. This scale has 23 items, each scored 0-4, and total score is mean item endorsement (sum of all items divided by 23). Higher scores indicate more symptom endorsement.	Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months)
Change in resting state brain connectivity	Patients get a 10 min brain scan (fMRI) without active task. Data are analysed to compare changes in intrinsic functional brain connectivity (BOLD activation of amygdala with other brain regions) during resting state before and after neurofeedback training.	Before treatment, immediately after treatment + follow-up measure (3 months)
Change in amygdala reactivity	Patients will perform a task, in which blocks of faces with negative emotional expressions and scrambled pictures will be presented. This task leads to considerable amygdala activation. With this task, we want to observe effects of neurofeedback on spontaneous amygdala activation.	Before treatment, immediately after treatment + follow-up measure (3 months)
Structural changes in the brain	By including DTI sequences before and after the neurofeedback intervention, we want to explore changes in FA/fiber structure of the brain. (exploratory analysis)	Before the first neurofeedback training and after the last neurofeedback training

Collaborators and Investigators

• Sponsor: Christian Paret
• Collaborators: Yale University; AE Foundation

Publications and helpful links

General Publications

• Zaehringer J, Ende G, Santangelo P, Kleindienst N, Ruf M, Bertsch K, Bohus M, Schmahl C, Paret C. Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder. Neuroimage Clin. 2019;24:102032. doi: 10.1016/j.nicl.2019.102032. Epub 2019 Oct 16.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 21, 2020
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: April 2, 2020
• First Posted (ACTUAL): April 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 7, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder
• Other Study ID Numbers: 2020-513N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No