Emotion Regulation Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Region Östergötland | Linköping |
Lead Sponsor | Collaborator |
---|---|
Region Östergötland |
Sweden,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05702086 -
Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression
|
N/A | |
Completed |
NCT05684614 -
Interoception and Emotion Regulation
|
||
Completed |
NCT05376397 -
Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)
|
N/A | |
Completed |
NCT04110548 -
Emotion and Craving Regulation Among Individuals With Internet Gaming Disorders
|
N/A | |
Not yet recruiting |
NCT05558527 -
The Social Regulation of Threat-related Vigilance and Arousal
|
N/A | |
Recruiting |
NCT03039387 -
Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients
|
N/A | |
Recruiting |
NCT06024083 -
Skills Video Intervention for Chinese/Chinese Americans
|
N/A | |
Recruiting |
NCT05867316 -
Supplementing Brief Psychotherapy With a Mobile App
|
N/A | |
Recruiting |
NCT05949047 -
Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease
|
N/A | |
Recruiting |
NCT06033053 -
Real-time Neurofeedback Training of Fronto-limbic Regions Functional Connectivity
|
N/A | |
Recruiting |
NCT05390034 -
Improving Emotion Regulation Flexibility: Testing the Efficacy of an Emotion Regulation Program in College Students
|
N/A | |
Recruiting |
NCT06432959 -
Incorporating Positive Affect Promoting Activities Into Cognitive Behavioral Therapies
|
N/A | |
Recruiting |
NCT05131425 -
Facing Your Fears: Adolescents With ASD and Intellectual Disability
|
N/A | |
Recruiting |
NCT06049407 -
Intervention on Socio-emotional Development and Well-being Through ICTs in Early Adulthood
|
N/A | |
Completed |
NCT04999514 -
Examining the Effects of Parenting Interventions on Children With Attention-Deficit / Hyperactivity Disorder (AD/HD) and Their Parents
|
N/A | |
Completed |
NCT05149066 -
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
|
N/A | |
Active, not recruiting |
NCT05264415 -
Intergenerational Transmission of Traumatic Stress
|
N/A | |
Recruiting |
NCT06458920 -
Social Facilitation of Emotion Regulation in Adolescence
|
N/A | |
Completed |
NCT03698591 -
Testing a Neurocognitive Model of Distancing Using Transcranial Magnetic Stimulation.
|
N/A | |
Active, not recruiting |
NCT05542498 -
Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation
|
N/A |