Neuro- and Biofeedback in Nonsuicidal Self-injury

NCT ID: NCT05656001

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-10
• Study Completion Date: 2024-03-31

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.

Conditions

Nonsuicidal Self Injury; Emotion Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

Participants will take part in three runs of real-time functional magnetic resonance imaging feedback (rt-fMRI-NF) training with 4-8 days apart, which will be conducted at the Center for Medical Image Science and Visualization (CMIV) at the university hospital in Linköping. Participants who receive biofeedback will take part in three runs of biofeedback with 4-8 days apart conducted in the lab at the Center for Social and Affective Neuroscience (CSAN) at Linköping university. Participants will be given instructions and basic psychoeducation of brain function and the rational for down-regulating the area of the brain that drives emotion, as well as the physiological reaction that is triggered in response to emotional stimuli. The emotional stimuli are emotional pictures from the International Affective Picture System (IAPS) and the Open Affective Standardized Image Set (OASIS).

Sham feedback

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

Group Type: SHAM_COMPARATOR

Sham functional magnetic resonance imaging neurofeedback and sham biofeedback

Intervention Type: OTHER

Participants will take part in three runs of sham neurofeedback with 4-8 days apart, which will be conducted at the Center for Medical Image Science and Visualization (CMIV) at the university hospital in Linköping. Participants who receive sham biofeedback will take part in three runs of sham biofeedback with 4-8 days apart conducted in the lab at the Center for Social and Affective Neuroscience (CSAN) at Linköping university. Participants will be given instructions and basic psychoeducation of brain function and the rational for down-regulating the area of the brain that drives emotion, as well as the physiological reaction that is triggered in response to emotional stimuli. The emotional stimuli are emotional pictures from the International Affective Picture System (IAPS) and the Open Affective Standardized Image Set (OASIS).

Interventions

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

Participants will take part in three runs of real-time functional magnetic resonance imaging feedback (rt-fMRI-NF) training with 4-8 days apart, which will be conducted at the Center for Medical Image Science and Visualization (CMIV) at the university hospital in Linköping. Participants who receive biofeedback will take part in three runs of biofeedback with 4-8 days apart conducted in the lab at the Center for Social and Affective Neuroscience (CSAN) at Linköping university. Participants will be given instructions and basic psychoeducation of brain function and the rational for down-regulating the area of the brain that drives emotion, as well as the physiological reaction that is triggered in response to emotional stimuli. The emotional stimuli are emotional pictures from the International Affective Picture System (IAPS) and the Open Affective Standardized Image Set (OASIS).

Intervention Type: OTHER

Sham functional magnetic resonance imaging neurofeedback and sham biofeedback

Participants will take part in three runs of sham neurofeedback with 4-8 days apart, which will be conducted at the Center for Medical Image Science and Visualization (CMIV) at the university hospital in Linköping. Participants who receive sham biofeedback will take part in three runs of sham biofeedback with 4-8 days apart conducted in the lab at the Center for Social and Affective Neuroscience (CSAN) at Linköping university. Participants will be given instructions and basic psychoeducation of brain function and the rational for down-regulating the area of the brain that drives emotion, as well as the physiological reaction that is triggered in response to emotional stimuli. The emotional stimuli are emotional pictures from the International Affective Picture System (IAPS) and the Open Affective Standardized Image Set (OASIS).

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Östergötland

OTHER

Sponsor Role: lead

Responsible Party

Maria Zetterqvist

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Zetterqvist, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Östergötland and Linköping university

Locations

Region Östergötland

Linköping, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Maria Zetterqvist, PhD

Role: CONTACT

maria.zetterqvist@regionostergotland.se

+46 10-1034339

Facility Contacts

Anna Elander

Role: primary

anna.elander@regionostergotland.se

Other Identifiers

2021-04702

Identifier Type: -

Identifier Source: org_study_id