ISRCTN37448835进行中（未招募）未知
fMRI investigation of the neural mechanisms of Emotional Cognitive Bias Modification as an adjunct therapy to SSRIs in depression.
niversity of Bristol0 个研究点目标入组 84 人开始时间: 2020年11月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 01/12/2022:
- •1. Aged 18 - 55 years
- •2. Have a new or first episode of depression (defined as not prescribed an antidepressant in the previous 6 months)
- •3. Prescribed a course of SSRI medication
- •4. Score >10 on the PHQ-9 assessment
- •Previous inclusion criteria:
- •1. Aged 18 - 55 years
- •2. Have a new or first episode of depression (defined as not prescribed an antidepressant in the previous 6 months)
- •3. Prescribed a course of sertraline medication
- •4. Score >10 on the PHQ-9 assessment
排除标准
- •Current exclusion criteria as of 01/12/2022:
- •1. Prescribed an antidepressant in the previous 6 months
- •2. Had a course of high intensity psychological treatment in the last 6 months
- •3. Alcohol or substance dependency
- •4. Bipolar disorder, Schizophrenia/Psychosis
- •5. Dementia
- •6. Currently under psychiatric care (including those referred but not yet seen) for depression
- •7. Unable to access online CBM sessions (PC, laptop, phone)
- •8. Cannot complete questionnaires unaided or would require an interpreter
- •9. Are taking part in another trial involving a psychological/drug intervention
- •10. Have a contra indication for fMRI scanning/imaging:
- •10.1 Significant hearing impairment (aids cannot be worn in the scanner)
- •10.2 Significant visual impairment that is not corrected by glasses/contact lenses eg, double vision or loss of vision in one eye, severe cataracts
- •10.3 Metal objects in or around the body which cannot be removed (braces, pacemaker, metal fragments, hearing devices, accidents involving metal fragments)
- •10.4 History of established central nervous system disease or injury (eg, cerebro-vascular disease, multiple sclerosis, Parkinson’s disease, traumatic brain injury)
- •10.5 Epilepsy, type 1 diabetes or thermoregulatory problems, including Raynaud's disease
- •10.6 Location sensitive tattoos to the head, neck, or genital area; (patients exceeding; tattoos covering >5% of the body; longest dimension>20cm; or multiple tattoos <20cm apart will be discussed with the radiographer).
- •10.7 Body Mass Index >35 kg/m²
- •10.8 Too physically unwell to tolerate a 30-minute fMRI scan, including musculo-skeletal disorders which make lying supine and still difficult
- •10.9 Claustrophobia
- •10.10 Pregnant or trying-to-become pregnant
- •10.11 We will ask participants not to take recreational drugs for 72 hours prior to each test session and not to drink alcohol for 24 hours prior to each test session
- •Previous exclusion criteria:
- •1. Prescribed an antidepressant in the previous 6 months
- •2. Had a course of high intensity psychological treatment in the last 6 months
- •3. Alcohol or substance dependency
- •4. Bipolar disorder, Schizophrenia/Psychosis
- •5. Dementia
- •6. Currently under psychiatric care (including those referred but not yet seen) for depression
- •7. Unable to access online CBM sessions (PC, laptop, phone)
- •8. Cannot complete questionnaires unaided or would require an interpreter
- •9. Are taking part in another trial involving a psychological/drug intervention
- •10. Have a contra indication for fMRI scanning/imaging:
- •10.1 Significant hearing impairment (aids cannot be worn in the scanner)
- •10.2 Significant visual impairment that is not corrected by glasses/contact lenses eg, double vision or loss of vision in one eye, severe cataracts
- •10.3 Metal objects in or around the body which cannot be removed (braces, pacemaker, metal fragments, hearing devices, accidents involving metal fragments)
- •10.4 History of established central nervous system disease or injury (eg, cerebro-vascular disease, multiple sclerosis, Parkinson’s disease, traumatic brain injury)
- •10.5 Epilepsy, diabetes or thermoregulatory problems, including Raynaud's disease
- •10.6 Extensive or location-sensitive tattoos, defined as covering >5% of the body; longest dimension> 20cm; multiple tattoos <20cm apart; tattoos to the head, neck or genital area
- •10.7 Body Mass Index >35 kg/m²
- •10.8 Too physically unwell to tolerate a 30-minute fMRI scan, including musculo-skeletal disorders which make lying supine and st
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