Identification of Prognostic Biomarkers by fMRI of Acceptance and Commitment Therapy in Suicidal Behavior Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task
研究概览
简要总结
Suicidal behaviors (SB) are a major health problem in France:10,000 suicides and 220,000 suicide attempts every year. SB management is therefore a major public health issue. Recently, investigators have demonstrated the interest of acceptance and commitment therapy (ACT) as an add-on treatment to reduce intensity and severity of suicidal ideation in depressed patients having a history of suicide attempt within previous year (i.e actual SB disorder according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)). Based on structural and functional findings, it is admitted orbitofrontal and ventral prefrontal cortices play a role in suicidal vulnerability. Interestingly, previous functional MRI (fMRI) studies have also reported the modulation of these regions by ACT in subjects suffering from chronic pain. fMRI could thus be an interesting tool to identify biomarkers of SB and its improvement by ACT.
The aim of study is to investigate neural biomarkers of ACT efficiency in patients with SB disorder. Patients having a history of SB within previous year were randomized in an ACT program (21 patients) or relaxation program (21 patients) during 7 weeks. Before and after the completion of the group, they performed 3 tasks during fMRI: implicit emotional visualization, Cyberball game, motivational task Investigators will compare cerebral activations between groups, between pre and post intervention as well as measure baseline cerebral activations associated with improvement of suicidal ideation during follow up.
详细描述
42 patients having a history of suicide attempt within the year preceding inclusion have been recruited.
First visit or inclusion (within 2 weeks preceding the beginning of the program): clinical, biological assessment and fMRI acquisition Second visit (within 2 weeks +/- 1 week following completion of the program): clinical assessment and fMRI acquisition Third visit (within 3 months +/- 2 weeks following completion of the program): clinical assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Baseline activation when viewing angry vs. neutral faces during an implicit emotional visualization task
时间窗: At 3 months after therapy
comparison between subjects with suicidal ideation vs. without suicidal ideation at 3 months after therapy
Variation of cerebral activation when viewing angry versus neural faces during an implicit emotional visualization task
时间窗: At 2 weeks after group completion
Comparison between inclusion and 2 weeks after group completion of cerebral activation within ACT group
次要结局
- Change of activation of default mode network (DMN) during resting state acquisition(Baseline acquisition and 2 weeks after therapy)
- Baseline activation of DMN during resting state acquisition(Baseline acquisition and clinical assessment at 3 months after therapy)
- Activation of specific brain regions when viewing sad, happy and disgust faces versus neutral faces during an implicit emotional visualization task(At the inclusion, and 2 weeks after the end of the therapy)
- Activation of specific brain regions during a motivational task(At the inclusion, and 2 weeks after the end of the therapy)
- Activation of specific brain regions during Cyberball game, a validated exclusion task(At the inclusion, and 2 weeks after the end of the therapy)
- Evolution of depressive state during the follow up measured by the Inventory of Depressive Symptomatology (IDSC-30)(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)
- Evolution of suicidal ideation measured by the Scale for Suicide Ideation (SSI)(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)
- Evolution of suicidal ideation measured by the Columbia Suicide Severity Rating Scale (CSSRS)(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)
- Baseline fraction of anisotropy(Baseline acquisition and clinical assessment at 3 months)
- Evolution of psychologic pain during the follow up(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)
- Evolution of depressive state during the follow up measured by the Quick Inventory of Depressive Symptomatology (QIDS-RS)(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)
- Evolution of anger during the follow up.(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)
- Evolution of clinical global impression during the follow up.(At the inclusion, 2 weeks after the end of the therapy and 3 months after the end of the therapy)