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Neuro- and Biofeedback in Nonsuicidal Self-injury

Primary Purpose

Nonsuicidal Self Injury, Emotion Regulation

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback
Sham functional magnetic resonance imaging neurofeedback and sham biofeedback
Sponsored by
Region Östergötland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonsuicidal Self Injury focused on measuring nonsuicidal self-injury, emotion regulation, adolescents, neurofeedback, biofeedback

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region ÖstergötlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

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

Sham feedback

Arm Description

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)

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

Outcomes

Primary Outcome Measures

Emotional reactivity
Changes of emotional reactivity is measured with facial electromyography (facialEMG). High zygomatic and corrugator response indicate higher emotional reactivity.
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.
Psychophysiological response
Changes of psychophysiological response during the real-time biofeedback training. The aim is to decrease the emotional reactivity and psychophysiological response.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 31, 2022
Last Updated
August 25, 2023
Sponsor
Region Östergötland
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1. Study Identification

Unique Protocol Identification Number
NCT05656001
Brief Title
Neuro- and Biofeedback in Nonsuicidal Self-injury
Official Title
Examining the Effects of Real-time fMRI Neurofeedback and Biofeedback in Adolescents With Nonsuicidal Self-injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsuicidal Self Injury, Emotion Regulation
Keywords
nonsuicidal self-injury, emotion regulation, adolescents, neurofeedback, biofeedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either an active feedback intervention or a control condition, consisting of a sham feedback.
Masking
ParticipantOutcomes Assessor
Masking Description
The participants and the outcomes assessor will not know if the participants receive actual or sham feedback.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real-time functional magnetic resonance imaging neurofeedback and real-time biofeedback
Arm Type
Experimental
Arm Description
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)
Arm Title
Sham feedback
Arm Type
Sham Comparator
Arm Description
Three session where participants will be given a yoked sham feedback as control condition.
Intervention Type
Other
Intervention Name(s)
Real-time functional magnetic resonance imaging Neurofeedback and Real-time Biofeedback
Intervention Description
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
Intervention Name(s)
Sham functional magnetic resonance imaging neurofeedback and sham biofeedback
Intervention Description
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).
Primary Outcome Measure Information:
Title
Emotional reactivity
Description
Changes of emotional reactivity is measured with facial electromyography (facialEMG). High zygomatic and corrugator response indicate higher emotional reactivity.
Time Frame
Change from baseline up to 5 weeks
Title
Hemodynamic activity
Description
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.
Time Frame
Change from baseline at up to 4 weeks
Title
Psychophysiological response
Description
Changes of psychophysiological response during the real-time biofeedback training. The aim is to decrease the emotional reactivity and psychophysiological response.
Time Frame
Change from baseline at up to 4 weeks
Secondary Outcome Measure Information:
Title
Nonsuicidal self-injury
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Title
Difficulties with emotion regulation
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Title
Emotional reactivity
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Title
Emotional awareness
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Title
Psychiatric symptoms
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Title
Self-criticism
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up
Title
Functions of nonsuicidal self-injury
Description
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.
Time Frame
Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Zetterqvist, PhD
Phone
+46 10-1034339
Email
maria.zetterqvist@regionostergotland.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Zetterqvist, PhD
Organizational Affiliation
Region Östergötland and Linköping university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Östergötland
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Elander
Email
anna.elander@regionostergotland.se
First Name & Middle Initial & Last Name & Degree
Maria Zetterqvist, PhD

12. IPD Sharing Statement

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Neuro- and Biofeedback in Nonsuicidal Self-injury

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