A Neurofeedback Booster for Emotion Regulation Therapy

Study Overview
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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.

Official Title
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BrainBoost - A Neurofeedback Booster for Emotion Regulation Therapy

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Neurofeedback


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Behavioral: Neurofeedback<br>* fMRI neurofeedback training of amygdala downregulation<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in emotion regulation | 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. | Before treatment, immediately after treatment + follow-up measure (3 months) | 
| Change in borderline symptomatology | 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. | Before treatment, immediately after treatment + 2 follow-up measures (3 months, 6 months) | 
| Change in resting state brain connectivity | 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. | Before treatment, immediately after treatment + follow-up measure (3 months) | 
| Change in amygdala reactivity | 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. | Before treatment, immediately after treatment + follow-up measure (3 months) | 
| Structural changes in the brain | By including DTI sequences before and after the neurofeedback intervention, we want to explore changes in FA/fiber structure of the brain. (exploratory analysis) | Before the first neurofeedback training and after the last neurofeedback training |