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Clinical Trials/NCT04333888
NCT04333888
Active, not recruiting
Not Applicable

BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy

Christian Paret1 site in 1 country44 target enrollmentJuly 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Borderline Personality Disorder
Sponsor
Christian Paret
Enrollment
44
Locations
1
Primary Endpoint
Change in affective instability
Status
Active, not recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 21, 2020
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Christian Paret
Responsible Party
Sponsor Investigator
Principal Investigator

Christian Paret

Principal Investigator

Central Institute of Mental Health, Mannheim

Eligibility Criteria

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
  • life-time diagnosis schizophrenia or bipolar disorder I
  • significant current or past neurological illness
  • BMI\<16.5
  • usual safety criteria for magnetic resonance imaging

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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