Randomized Controlled Trials to Measure Neurophysiological Effects Using EEG Signals, Artificial Intelligence and Neuropsychological Techniques of a Mindfulness-Based Intervention in Young Adults with Symptoms of Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Neurophysiological measures
研究概览
简要总结
Depression and anxiety are conditions with a high prevalence in the world population and youth are no exception. In developing countries it is reported that given the conditions of social disadvantage, anxiety and depression are higher, resulting in compromised psychological well-being and mental health. Therefore, treatments that help in the care and prevention of these disorders from youth are important. In the case of contemporary psychology, Mindfulness treatments have emerged as an alternative treatment for some of the symptoms of depression, anxiety and emotional discomfort, showing evidence of increased improvement in the overall quality of life. The project responds to global mental health demands and will provide the institution, as well as external collaborating institutions and society in general, with guidelines to carry out brief and effective interventions for these problems and will develop clinical evidence and technological tools for their analysis. Objective: To compare the neurophysiological effects by means of EEG signals and machine learning or deep learning techniques and neuropsychological effects of a brief treatment based on mindfulness-based intervention techniques as an alternative intervention for the reduction of anxiety and depression symptoms against the effects of psychoeducation groups and placebo group in young adults. Methodology: Factorial design of cases and controls according to the guidelines for randomized controlled trials CONSORT. Participants (n=125) will be randomized triple-blinded with neuropsychological and neurophysiological assessments. The results of the project will generate basic evidence on the condition of brain functioning at the neurophysiological level, its performance to perform processes of utmost relevance to solve daily life problems and psychological well-being, as well as support the development of techniques for specialists in behavioral analysis and mental health and engineering sciences for the creation and implementation of programs and strategies for the prevention, identification, care and evaluation of mental health and social well-being, with a scientific and community health approach.
详细描述
Protocol
Study type. Factorial case-control design according to the guidelines for CONSORT randomized controlled trials (Cuschieri, 2019). Participants will be randomized triple-blinded.
Stage 1. Clinical Trials Registration. Involvement Participant eligibility assessments (n = 125). Participant permanence analysis, inclusion and exclusion criteria. Randomized groups (n = 125) Blinded 1 Group assignment A = placebo treatment control group, B = mindfulness-based intervention group, C = PE-based intervention group.
Randomization of participants to the intervention Blind 2 Group 1: A Group 2: B Group 3: C A homologous rate of group assignment will be maintained. Neuropsychological assessment measurements and neurophysiological measures Neuropsychological assessment
To measure changes in the functioning of the cognitive processes of interest (Executive Functions, Attention, Memory and Social Cognition) we propose to use the following assessment instruments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young adults 18-30 years old
- •University students enrolled in any of the Autonomous University of Baja California programs.
- •To properly accomplish to all assessment procedures
- •To properly accomplish at least 80% of the intervention sessions
- •Interest to voluntarly participate.
排除标准
- •Disgnosis of neurological or psychitric disease, including severe anxiety or depression.
- •Incomplete protocol evaluation.
- •Out of 18-30 years old range age.
- •Being enrolled in a different psychological or psychiatric intervention or treatment program during the period of evaluation and intervention.
结局指标
主要结局
Neurophysiological measures
时间窗: Pre-post intervention assessment, after 8 weeks. A follow-up measure will be recorded immidiatly after each intervention session, 8 weeks as well.
Neurophysiological, electroencephalographic (EEG) recordings will be performed: Each participant will undergo a five minute EEG recording in resting state, previous to any intervention, 128 Hz sampling rate, from 8 ch, EMOTIV Epoc (AF3, AF4, F3, F4, F7, F8, FC5, FC6), with saline solution for conductivity improvement. Offline EEG features frontal alpha-beta proportion change (if any) will be calculated using windowing power spectra transform. Follow-up five minutes, recordings after each intervention session and post-intervention program will be performed as well.
Mood measures
时间窗: Pre-post intervention assessment, after 8 weeks.
Anxiety and depression index will be calculated from Beck's adapted and validated version to Mexican population. Scores range from 0 min-30 max, normal score ranges from 25-30.
Card Sorting Test
时间窗: Pre-post intervention assessment, after 8 weeks.
Card Sorting Test, will be measured from the standardized executive function test BANFE, using accurcy of response, perseverations, time, and errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Self directed signaling
时间窗: Pre-post intervention assessment, after 8 weeks.
Self directed signaling, will be measured from the standardized executive function test BANFE, using accuracy of response, time, and errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Stroop Test
时间窗: Pre-post intervention assessment, after 8 weeks.
Stroop test, will be measured from the standardized executive function test BANFE, using accuracy of response, stroop type error, no-Stroop errors, and time, Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Working memory
时间窗: Pre-post intervention assessment, after 8 weeks.
Working Memory will be measured from the standardized executive function test BANFE, using accuracy of response as scoring criteria. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Gambling test
时间窗: Pre-post intervention assessment, after 8 weeks.
Gambling test, will be measured by calculating EF quotients from the standardized test BANFE using risk cards percentage, final total score. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Tower of Hanoi
时间窗: Pre-post intervention assessment, after 8 weeks.
Tower of Hanoi, using number of movements, and time, will be measured by calculating EF quotients from the standardized test BANFE. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Metamemory
时间窗: Pre-post intervention assessment, after 8 weeks.
Metamemory, will be measured by calculating EF quotients from the standardized test BANFE using positive and negative errors. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).
Neuropsychological evaluation
时间窗: Pre-post intervention assessment, after 8 weeks.
Attention and Memory, normilized quotient will be calculated according to NEUROPSI standard Attention and Memory Standardized test, using accuracy of response, and time as direct measures of each task. Attention and memory score is normalized according to age and years of education, scores range from 1-19 (1-3 extremely low, 4-6 low, 7-13 normal, 14-19 high performance).
Neuropsychological measure
时间窗: Pre-post intervention assessment, after 8 weeks.
Social Cognition, according to index from computarized adapted version of the Mind in the Eyes test, index 0 (min) - 36 (max) score, expected score ranges from 25-36.
次要结局
未报告次要终点
研究者
Gilberto Galindo
Full time Professor
Universidad Autonoma de Baja California