- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656001
Neuro- and Biofeedback in Nonsuicidal Self-injury
August 25, 2023 updated by: Maria Zetterqvist, Region Östergötland
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Zetterqvist, PhD
- Phone Number: +46 10-1034339
- Email: maria.zetterqvist@regionostergotland.se
Study Locations
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Linköping, Sweden, 581 85
- Recruiting
- Region Östergötland
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Contact:
- Anna Elander
- Email: anna.elander@regionostergotland.se
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Principal Investigator:
- Maria Zetterqvist, PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
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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).
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Sham Comparator: Sham feedback
Three session where participants will be given a yoked sham feedback as control condition.
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change from baseline up to 5 weeks
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Hemodynamic activity
Time Frame: Change from baseline at up to 4 weeks
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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.
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Change from baseline at up to 4 weeks
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Psychophysiological response
Time Frame: Change from baseline at up to 4 weeks
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Changes of psychophysiological response during the real-time biofeedback training.
The aim is to decrease the emotional reactivity and psychophysiological response.
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Change from baseline at up to 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nonsuicidal self-injury
Time Frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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Difficulties with emotion regulation
Time Frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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Emotional reactivity
Time Frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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Emotional awareness
Time Frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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Psychiatric symptoms
Time Frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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Self-criticism
Time Frame: Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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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
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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.
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Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maria Zetterqvist, PhD, Region Östergötland and Linköping university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2021
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
December 9, 2022
First Posted (Actual)
December 19, 2022
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 25, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-04702
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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