Neuro- and Biofeedback in Nonsuicidal Self-injury

Region Östergötland

Status: Enrolling

Conditions: Nonsuicidal Self Injury; Emotion Regulation

Treatments: Other: Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback; Other: Sham functional magnetic resonance imaging neurofeedback and sham biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05656001

2021-04702

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

real-time functional magnetic resonance imaging neurofeedback and real-time biofeedback

Experimental group

Description:

Three sessions of real-time functional magnetic resonance imaging neurofeedback (rt-fMRI-NF) or real-time biofeedback training where participants will receive direct visual feedback from the blood oxygenation level dependent (BOLD) imaging signaling from the salience network in rt-fMRI-NF or visual feeback from a physiological signal in the real-time biofeedback (active condition)

Treatment:

Other: Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback

Sham feedback

Sham Comparator group

Description:

Three session where participants will be given a yoked sham feedback as control condition.

Treatment:

Other: Sham functional magnetic resonance imaging neurofeedback and sham biofeedback