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NCT Number: NCT04333888

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Borderline Personality Disorder Mental Disorders Personality Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Institute of Mental Health

Mannheim, 68159, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurofeedback

Behavioral

fMRI neurofeedback training of amygdala downregulation

Primary outcomes

  1. Change in affective instability

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

    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.

Secondary outcomes

  1. Change in emotion regulation

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

    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.

  2. Change in borderline symptomatology

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

    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.

  3. Change in resting state brain connectivity

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

    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.

  4. Change in amygdala reactivity

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

    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.

  5. Structural changes in the brain

    Time frame: Before the first neurofeedback training and after the last neurofeedback training

    By including DTI sequences before and after the neurofeedback intervention, we want to explore changes in FA/fiber structure of the brain. (exploratory analysis)

Sponsors and collaborators

Lead sponsor

Christian Paret

Other

Collaborators

  • AE Foundation
  • Yale University

Registry information

Official study title

BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy

Acronym: BrainBoost

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Apr 3, 2020
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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