Nonsuicidal Self InjuryNCT05656001
Neuro- and Biofeedback in Nonsuicidal Self-injury
A study testing Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback in people with Nonsuicidal Self Injury and Emotion Regulation, run by Region Östergötland at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Nonsuicidal Self Injury, Emotion Regulation
- What is being tested?
- Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2021to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Östergötland
Linköping, 581 85
Anna Elander, anna.elander@regionostergotland.se
Maria Zetterqvist, PhD
About this study
Official title: Examining the Effects of Real-time fMRI Neurofeedback and Biofeedback in Adolescents With Nonsuicidal Self-injury
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
- Being tested
- Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback, Sham functional magnetic resonance imaging neurofeedback and sham biofeedback
- Keywords
- nonsuicidal self-injury, emotion regulation, adolescents, neurofeedback, biofeedback
- Medical subject headings
- Self-Injurious Behavior, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time functional magnetic resonance imaging Neurofeedback and Real-time BiofeedbackOther
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 biofeedbackOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Other: Sham functional magnetic resonance imaging neurofeedback and sham biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional reactivity
Changes of emotional reactivity is measured with facial electromyography (facialEMG). High zygomatic and corrugator response indicate higher emotional reactivity.
Measured: 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.
Measured: 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.
Measured: Change from baseline at up to 4 weeks
Secondary outcomes (7)
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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.
Measured: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start10 Sep 2021
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsuicidal Self InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either an active feedback intervention or a control condition, consisting of a sham feedback.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Zetterqvist, Region Östergötland
- Investigators
- Maria Zetterqvist, PhD, Principal investigator, Region Östergötland and Linköping university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656001
- Sponsor's protocol ID
- 2021-04702
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Real-time fMRI Neurofeedback and Biofeedback in Adolescents With Nonsuicidal Self-injury
- ClinicalTrials.gov ID
- NCT05656001
- Acronym / sponsor ID
- 2021-04702
- Conditions
- Nonsuicidal Self Injury, Emotion Regulation
- Keywords
- nonsuicidal self-injury, emotion regulation, adolescents, neurofeedback, biofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either an active feedback intervention or a control condition, consisting of a sham feedback.
| Arm | Type | Receives |
|---|---|---|
| real-time functional magnetic resonance imaging neurofeedback and real-time biofeedback | Experimental | Other: Real-time functional magnetic resonance imaging Neurofeedback and Real-time BiofeedbackThree 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) |
| Sham feedback | Sham comparator | Other: Sham functional magnetic resonance imaging neurofeedback and sham biofeedbackThree session where participants will be given a yoked sham feedback as control condition. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- anorexia in starvation with BMI 16 or under
- substance abuse disorder
- psychosis
- needing interpreter
- intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time functional magnetic resonance imaging Neurofeedback and Real-time BiofeedbackParticipants 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). | Other | real-time functional magnetic resonance imaging neurofeedback and real-time biofeedback |
| Sham functional magnetic resonance imaging neurofeedback and sham biofeedbackParticipants 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). | Other | Sham feedback |
Primary outcome
Emotional reactivity
Time frame: Change from baseline up to 5 weeks
Changes of emotional reactivity is measured with facial electromyography (facialEMG). High zygomatic and corrugator response indicate higher emotional reactivity.
Hemodynamic activity
Time frame: Change from baseline at up to 4 weeks
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.
Psychophysiological response
Time frame: Change from baseline at up to 4 weeks
Changes of psychophysiological response during the real-time biofeedback training. The aim is to decrease the emotional reactivity and psychophysiological response.
7 secondary outcomes
Nonsuicidal self-injury
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Difficulties with emotion regulation
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Emotional reactivity
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Emotional awareness
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Psychiatric symptoms
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Self-criticism
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Functions of nonsuicidal self-injury
Time frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Zetterqvist, PhD principal investigator
Region Östergötland and Linköping university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback in people with Nonsuicidal Self Injury and Emotion Regulation, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Zetterqvist, PhD (+46 10-1034339, maria.zetterqvist@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional reactivity (time frame: Change from baseline up to 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.