A Neurofeedback Booster for Emotion Regulation Therapy (BrainBoost)

Christian Paret

Status: Active, not recruiting

Conditions: Borderline Personality Disorder

Treatments: Behavioral: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04333888

2020-513N

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Treatment

Experimental group

Treatment:

Behavioral: Neurofeedback

Control

No Intervention group