Neuro- and Biofeedback in Nonsuicidal Self-injury

NCT05656001 | Unknown

• 1 other identifier: 2021-04702
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

nonsuicidal self-injury; emotion regulation; adolescents; neurofeedback; biofeedback

Outcome Measures

Primary Outcomes (3)

• Emotional reactivity

  Changes of emotional reactivity is measured with facial electromyography (facialEMG). High zygomatic and corrugator response indicate higher emotional reactivity.

  Change from baseline up to 5 weeks

• Hemodynamic activity

  Changes of the blood oxygenation level dependent (BOLD) response during real-time fMRI-neurofeedback for the neurofeedback training. The aim is to down-regulate the hemodynamic activity in the salience network.

  Change from baseline at up to 4 weeks

• Psychophysiological response

  Changes of psychophysiological response during the real-time biofeedback training. The aim is to decrease the emotional reactivity and psychophysiological response.

  Change from baseline at up to 4 weeks

Secondary Outcomes (7)

• Nonsuicidal self-injury

  Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up

• Difficulties with emotion regulation

  Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up

• Emotional reactivity

  Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up

• Emotional awareness

  Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up

• Psychiatric symptoms

  Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up

Study Arms (2)

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

EXPERIMENTAL

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)

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

Sham feedback

SHAM COMPARATOR

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

Other: Sham functional magnetic resonance imaging neurofeedback and sham biofeedback

Interventions

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

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

Sham functional magnetic resonance imaging neurofeedback and sham biofeedback 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).

Sham feedback

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Östergötland: lead

Study Sites (1)

Region Östergötland

Linköping, 581 85, Sweden

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Emotional Regulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Maria Zetterqvist, PhD

  Region Östergötland and Linköping university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Zetterqvist, PhD

CONTACT

+46 10-1034339; maria.zetterqvist@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcomes assessor will not know if the participants receive actual or sham feedback.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be randomized to either an active feedback intervention or a control condition, consisting of a sham feedback.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: December 19, 2022
• Study Start: September 10, 2021
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

SE (1)