A Neurofeedback Booster for Emotion Regulation Therapy

NCT04333888 | Active Not Recruiting

• 1 other identifier: 2020-513N
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in emotion regulation

  Before treatment, immediately after treatment + follow-up measure (3 months)

• Change in borderline symptomatology

  Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months)

• Change in resting state brain connectivity

  Before treatment, immediately after treatment + follow-up measure (3 months)

• Change in amygdala reactivity

  Before treatment, immediately after treatment + follow-up measure (3 months)

• Structural changes in the brain

  Before the first neurofeedback training and after the last neurofeedback training

Study Arms (2)

Treatment

EXPERIMENTAL

Behavioral: Neurofeedback

Control

NO INTERVENTION

Interventions

Neurofeedback BEHAVIORAL

fMRI neurofeedback training of amygdala downregulation

Treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Paret: lead
• Yale University: collaborator
• AE Foundation: collaborator

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

Location

Related Publications (1)

• 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.

  PMID: 31795041 BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 3, 2020
• Study Start: July 21, 2020
• Primary Completion: February 28, 2024
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)