A Randomised Controlled Trial of FMRI-neurofeedback in Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Post-intervention score for the 30 item Inventory of Depressive Symptomatology (IDS)
研究概览
简要总结
Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction. The goal of this clinical trial is to compare fMRI-neurofeedback plus standard care with standard care in patients with depression.
Participants will either receive standard care, or standard care plus a fMRI neurofeedback training, consisting of 5 neurofeedback training sessions. Symptom severity will be assessed before, immediately after and 6 months after the intervention.
详细描述
Rationale: Previous studies with fMRI-neurofeedback in depression have demonstrated a good safety profile and considerable symptom reduction but a comparison between standard care and standard care plus fMRI-neurofeedback has not yet been carried out.
Objective: To assess the efficacy of fMRI-neurofeedback plus standard care in comparison with standard care in patients with depression.
Study design: Single-blind RCT. Patients will be randomly allocated to fMRI-neurofeedback plus standard care or standard care. Assessments will be conducted by assessors who are blinded to group allocation.
Patients will be randomised to the two groups using a block randomisation procedure (10 participants per block). Depression severity at baseline (IDS scores) will be used as minimisation variable to ensure equal severity in both groups. The study team will receive a code for group allocation. The study team and patient will be aware of the group allocation (by the nature of the study design), but assessors performing baseline, post-intervention and follow-up assessments will be blinded. During interim analyses, the analysts will remain blinded to the conditions.
If the stopping criterion is reached before the maximal N, any patients already randomised will complete the study and their data will be included in the secondary analyses.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a depressive disorder (ICD-10: F32 or F33)
- •Has been on stable antidepressant medication (single or combination treatment) for at least 4 weeks
- •Current depression (QIDS >= 17)
- •If required to meet recruitment targets the minimum entry score will be reduced QIDS >= 13 (i.e. still corresponding to a moderate level of depression)
排除标准
- •Exclusion criteria for MRI (e.g. cardiac pacemaker, certain metallic implants)
- •History of psychotic disorder bipolar disorder, or psychotic depression
- •Current use of illegal drugs (any in the last four weeks)
- •Current excessive alcohol consumption that interferes with daily functioning
- •History of neurological disease that could influence the fMRI signal and/or the anatomical alignment (e.g. territorial stroke, multiple sclerosis, brain tumour)
结局指标
主要结局
Post-intervention score for the 30 item Inventory of Depressive Symptomatology (IDS)
时间窗: End of intervention: appr. 2 months after baseline
30 item clinician rated depression scale (Rush et al., 1986; Rush, Gullion, Basco, Jarrett, \& Trivedi, 1996)
次要结局
- Six month follow-up score for the 30 item Inventory of Depressive Symptomatology (IDS)(6-month follow-up)
- Post-intervention score for the Beck Depression Inventory (BDI)(End of intervention: appr. 2 months after baseline)
- Post-intervention score for the Hospital Anxiety and Depression Scale (HADS)(End of intervention: appr. 2 months after baseline)
- Post-intervention score for the Quality Of Life scale (QOLS)(End of intervention: appr. 2 months after baseline)
- Six month follow-up score for the Hospital Anxiety and Depression Scale (HADS)(6-month follow-up)
- Six month follow-up score for the Beck Depression Inventory (BDI)(6-month follow-up)
- Six month follow-up score for the Quality Of Life scale (QOLS)(6-month follow-up)
- Post-intervention score for the EuroQol research foundation questionnaire (EQ-5D-5L)(End of intervention: appr. 2 months after baseline)
- Experience sampling of mood states, somatic symptoms and activities using the PsyMate application(1 week after baseline, 1 week before the end of intervention measurement)
- Six month follow-up score for the EuroQol research foundation questionnaire (EQ-5D-5L)(6-month follow-up)
- Post-intervention score for the Self Efficacy Scale (SES)(End of intervention: appr. 2 months after baseline)
- Six month follow-up score for the Self Efficacy Scale (SES)(6-month follow-up)