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临床试验/NCT05656001
NCT05656001招募中不适用

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

Region Östergötland2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Emotional reactivity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The participants and the outcomes assessor will not know if the participants receive actual or sham feedback.

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Emotional reactivity

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Nonsuicidal self-injury(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)
  • Emotional reactivity(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)
  • Emotional awareness(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)
  • Difficulties with emotion regulation(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)
  • Psychiatric symptoms(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)
  • Self-criticism(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)
  • Functions of nonsuicidal self-injury(Change from baseline at up to 5 weeks, and at additional 6 weeks and 3 month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Zetterqvist

Principal investigator

Region Östergötland

研究点 (2)

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Neuro- and Biofeedback in Nonsuicidal Self-injury | 临床试验