Clinical trial NCT05656001: Neuro- and Biofeedback in Nonsuicidal Self-injury
Official title: Examining the Effects of Real-time fMRI Neurofeedback and Biofeedback in Adolescents With Nonsuicidal Self-injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nonsuicidal Self Injury
Emotion Regulation
Keywords: nonsuicidal self-injury
emotion regulation
adolescents
neurofeedback
biofeedback
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either an active feedback intervention or a control condition, consisting of a sham feedback.
Primary purpose: TREATMENT

Brief summary: Nonsuicidal self-injury (NSSI) is defined as the direct, deliberate destruction of one's own body tissue without suicidal intent, typically including behaviors such as cutting, burning, or hitting oneself. The risk of engaging in NSSI is particularly high during adolescence. NSSI is associated with impairments in emotion regulation and NSSI behavior serves as an attempt to regulate emotion. We propose to examine whether training adolescents with NSSI to self-regulate using emotion regulation skills to down-regulate hemodynamic activity of the salience network, involved in emotional processing. Moreover, we propose to examine whether limbic-prefrontal cortex connectivity can be increased following neurofeedback, thereby helping adolescents find an optimal way to emotionally regulate with the help of neurofeedback, instead of engaging in NSSI to regulate emotions. We also aim to examine effects of real-time biofeedback by investigating if adolescents can regulate their psychophysiological activity during emotional reactivity with biofeedback. Sixty participants with NSSI will be recruited and offered either real-time functional magnetic resonance imaging (rt-fMRI-NF) (n = 30) or real-time biofeedback (n = 30) training. Participants each each condition will then be randomized to either an active or a control condition (n = 15/group). Participants will take part in three runs of feedback training. Changes in emotional reactivity as measured with facial electromyography (EMG) before and after feedback training will be the proximal outcome measure together with changes of the blood oxygenation level dependent (BOLD) response during real-time fMRI-neurofeedback for the neurofeedback training. Proximal outcome measures for the biofeedback will include psychophysiological measures of emotional reactivity (facialEMG). More distal outcome measures for both neuro- and biofeedback will be measures of NSSI: frequency, methods and severity as well as self-report measures of difficulties with regulating emotions, emotional reactivity and psychiatric symptoms.


Eligibility criteria: Inclusion Criteria:

* ongoing contact at the child- and adolescent psychiatric clinics in both Linköping and Norrköping, Sweden
* ongoing contact at the primary care facilities in Linköping and Norrköping (Ungdomshälsan, Råd, Stöd \& Hälsa)
* NSSI, independent of psychiatric diagnosis
* between 15 and 19 years of age
* having engaged in five or more instances of NSSI during the last six months
* the patient is cognitively capable to decide for him- or herself

Exclusion Criteria:

* anorexia in starvation with BMI 16 or under
* substance abuse disorder
* psychosis
* needing interpreter
* intellectual disability
* and for those who do the neurofeedback, severe claustrophobia, pregnancy and braces

Primary outcomes:
measure: Emotional reactivity
timeFrame: Change from baseline up to 5 weeks
measure: Hemodynamic activity
timeFrame: Change from baseline at up to 4 weeks
measure: Psychophysiological response
timeFrame: Change from baseline at up to 4 weeks
Secondary outcomes:
measure: Nonsuicidal self-injury
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
measure: Difficulties with emotion regulation
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
measure: Emotional reactivity
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
measure: Emotional awareness
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
measure: Psychiatric symptoms
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
measure: Self-criticism
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
measure: Functions of nonsuicidal self-injury
timeFrame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Region Östergötland
Study officials:
affiliation: Region Östergötland and Linköping university
name: Maria Zetterqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: