Neuro- and Biofeedback in Nonsuicidal Self-injury

Emotion Regulation Clinical Trial

Official title:

Examining the Effects of Real-time fMRI Neurofeedback and Biofeedback in Adolescents With Nonsuicidal Self-injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656001
• Other study ID #: 2021-04702
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: Region Östergötland
• Contact: Maria Zetterqvist, PhD
• Phone: +46 10-1034339
• Email: maria.zetterqvist[@]regionostergotland.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotion Regulation
• Nonsuicidal Self Injury
• Self-Injurious Behavior
• Wounds and Injuries

Intervention

Other:
• 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).
• 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).

Locations

Country	Name	City	State
Sweden	Region Östergötland	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Nonsuicidal self-injury	Changes of self-reported frequency in nonsuicidal self-injury (NSSI). NSSI frequency is measured using the short 9-item version of the Deliberate Self-Harm Inventory (DSHI). Open ended questions are used for frequency with a range from 0 to several hundreds, depending on participants answers. Higher scores indicate more NSSI frequency and worse outcome.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Secondary	Difficulties with emotion regulation	Changes of self-reported difficulties with emotion regulation. Difficulties with emotion regulation is measured using the 16-item version of the Difficulties with Emotion Regulation Scale (DERS-16). Scores range from 16 to 80 where higher scores indicate more difficulties with emotion regulation.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Secondary	Emotional reactivity	Changes of self-reported emotional reactivity. Emotional reactivity is measured with the Emotion Reactivity Scale (ERS). Total scores range from 0 to 84 and a higher score indicates a worse outcome.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Secondary	Emotional awareness	Changes of self-reported emotional awareness. Emotional awareness is measured with Toronto Alexithymia Scale, 20 items (TAS-20). TAS-20 total score ranges from 20 to 100 and higher scores indicate worse outcome.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Secondary	Psychiatric symptoms	Changes of self-reported psychiatric symptoms. Psychiatric symptomatology is measured with the Trauma Symptom Checklist for Children (TSCC) with subscales: depression, anxiety, dissociation, posttraumatic stress, anger and sexual preoccupation. The total scale ranges from 0 to 162 and higher scores indicate worse outcome.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Secondary	Self-criticism	Changes of self-reported levels of self-criticism. Self-criticism is measured with the Self-Rating Scale (SRS). Scores range from 8 to 56, and higher scores indicate higher levels of self-criticism.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Secondary	Functions of nonsuicidal self-injury	Changes of self-reported levels of nonsuicidal self-injury (NSSI) functions. NSSI functions is measured using Clinical Assessment of Nonsuicidal Self-Injury Disorder Index (CANDI). Functions are rated as percentages and scores range from 0 to 100% where higher scores indicate higher usage of a specific NSSI function.	Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up