A Neurofeedback Booster for Emotion Regulation Therapy

NCT ID: NCT04333888

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-21

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Borderline Personality Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type BEHAVIORAL

fMRI neurofeedback training of amygdala downregulation

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Neurofeedback

fMRI neurofeedback training of amygdala downregulation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

AE Foundation

OTHER

Sponsor Role collaborator

Christian Paret

OTHER

Sponsor Role lead

Responsible Party

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Christian Paret

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Central Institute of Mental Health

Mannheim, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 31795041 (View on PubMed)

Other Identifiers

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2020-513N

Identifier Type: -

Identifier Source: org_study_id

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