Understanding Mechanisms of Prevention of Depression: a Mechanistic Cross-over Trial of Mindfulness vs. Fantasizing to Reduce Perseverative Cognition Underlying Vulnerability for Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Dysfunctional Attitude Scale
研究概览
简要总结
The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.
详细描述
A cross-over design will be used comparing measures before and during both a mindfulness- and a positive fantasizing intervention period in individuals who remitted from two major depressive episodes (i.e. remitted Major Depressive Disorder (rMDD) patients) and a never-depressed control group. After checking for eligibility of the participants, participants will fill-out several questionnaires about their personal characteristics, experiences and expectations. These questionnaires will be used to study individual characteristics that could serve as treatment markers predicting the effectivity of interventions. Furthermore, diary measures of thought patterns (experience sampling method [ESM]), behavioural measures (using the Sustained Attention to Response Task [SART]), actigraphy, (neuro)physiological measures (impedance cardiography [ICG], electrocardiography [ECG] and electroencephalogram [EEG]) and measures of depressive mood (self-report questionnaires) will be performed during the week before (pre-) the interventions and the week during (peri-) performance of the interventions. In-between pre-and peri-intervention measures, there is a one month wash-out period. The order of the interventions will be counterbalanced across participants. Pre- and peri-intervention measures will be compared to study intervention effects in remitted MDD patients, remitted MDD patients vs. healthy controls and in relation with individual characteristics
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, all participants must meet all the following criteria:
- •Participants should be between 18 and 60 years old. Participants should not exceed 60 years of age in order to minimize aging-related decline in information processing;
- •Participants should display normal intelligence (IQ>85, as assessed with the Dutch Adult Reading Test and/or having finished an education on at least vocational level) in order to assure sufficient task comprehension.
- •Participants in the remitted Major Depressive Disorder group should meet the following criteria to make sure that participants are at high risk of depressive relapse and currently show no clinically relevant severity of depressive symptoms:
- •Remitted participants should have experienced at least two depressive episodes, according to criteria defined by the Diagnostic Statistical Manual, version 5 (DSM-5), experienced in past ten years;
- •Remitted participants should score 21 or lower on the Inventory of Depressive Symptomatology (IDS-SR30), indicative of the absence of clinically relevant depressive symptoms.
排除标准
- •Furthermore, individuals who meet any of the following criteria will be excluded from participation in this study:
- •Fulfilling criteria for any current DSM-5 diagnosis as objectified with the Structured Clinical Interview for DSM-5 (SCID-5);
- •Daily use of anti-depressive medication, benzodiazepines, methylphenidate, beta blockers or other medication potentially influencing electrocardiogram currently or in the last four weeks;
- •Recent engagement (defined as in their last episode, or as one year prior to inclusion in case the last episode was more than a year before inclusion) in preventive cognitive therapy including the positive fantasizing technique and/or have recent experiences (defined as daily practice in the past two years for at least two weeks) with mindfulness, meditation, or mindful yoga. This criterion prevents underestimation of true effects of mindfulness and/or positive fantasizing and maximizes treatment effects;
- •Participation in another clinical intervention study at the moment of inclusion in the study to prevent overlapping intervention effects.
- •Individuals for the Never-Depressed control group who additionally meet any of the following criteria will be excluded from participation of this study:
- •Presence of symptoms of depression according to the IDS-SR30 (score > 13), to make sure participants are not currently experiencing clinically relevant depressive symptoms;
- •Any life-time psychopathology of any disorder as objectified with the SCID-5.
研究组 & 干预措施
Mindfulness first intervention, Fantasizing second intervention
Diary measures of thought patterns (experience sampling method [ESM]), behavioural measures (using the Sustained Attention to Response Task [SART]), actigraphy, (neuro)physiological measures (impedance cardiography [ICG], electrocardiography [ECG] and electroencephalogram [EEG]) and measures of depressive mood (self-report questionnaires) will be performed during the week before (pre-) the interventions and the week during (peri-) performance of the interventions. In-between pre-and peri-intervention measures, there is a one month wash-out period. In this arm mindfulness will be the first performed intervention, fantasizing the second performed intervention. The order of the interventions will be counterbalanced across participants.
干预措施: Mindfulness (Behavioral)
Mindfulness first intervention, Fantasizing second intervention
Diary measures of thought patterns (experience sampling method [ESM]), behavioural measures (using the Sustained Attention to Response Task [SART]), actigraphy, (neuro)physiological measures (impedance cardiography [ICG], electrocardiography [ECG] and electroencephalogram [EEG]) and measures of depressive mood (self-report questionnaires) will be performed during the week before (pre-) the interventions and the week during (peri-) performance of the interventions. In-between pre-and peri-intervention measures, there is a one month wash-out period. In this arm mindfulness will be the first performed intervention, fantasizing the second performed intervention. The order of the interventions will be counterbalanced across participants.
干预措施: Positive Fantasizing (Behavioral)
Fantasizing first intervention, Mindfulness second intervention
Diary measures of thought patterns (experience sampling method [ESM]), behavioural measures (using the Sustained Attention to Response Task [SART]), actigraphy, (neuro)physiological measures (impedance cardiography [ICG], electrocardiography [ECG] and electroencephalogram [EEG]) and measures of depressive mood (self-report questionnaires) will be performed during the week before (pre-) the interventions and the week during (peri-) performance of the interventions. In-between pre-and peri-intervention measures, there is a one month wash-out period. In this arm fantasizing will be the first performed intervention, mindfulness the second performed intervention. The order of the interventions will be counterbalanced across participants.
干预措施: Mindfulness (Behavioral)
Fantasizing first intervention, Mindfulness second intervention
Diary measures of thought patterns (experience sampling method [ESM]), behavioural measures (using the Sustained Attention to Response Task [SART]), actigraphy, (neuro)physiological measures (impedance cardiography [ICG], electrocardiography [ECG] and electroencephalogram [EEG]) and measures of depressive mood (self-report questionnaires) will be performed during the week before (pre-) the interventions and the week during (peri-) performance of the interventions. In-between pre-and peri-intervention measures, there is a one month wash-out period. In this arm fantasizing will be the first performed intervention, mindfulness the second performed intervention. The order of the interventions will be counterbalanced across participants.
干预措施: Positive Fantasizing (Behavioral)
结局指标
主要结局
Dysfunctional Attitude Scale
时间窗: At baseline before the start of the measurement weeks
Self-report questionnaire measuring dysfunctional attitudes (higher score reflects higher dysfunctional attitudes) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.
Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram.
时间窗: 24 hours
Physiological correlates of perseverative cognition measure das heart rate variability measured with electrocardiogram
Apathy Evaluation Scale
时间窗: At baseline before the start of the measurement weeks
Self-report questionnaire measuring apathy levels (higher score reflects higher apathy levels) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.
Bermond-Vorst Alexithymia Questionnaire
时间窗: At baseline before the start of the measurement weeks
Self-report questionnaire measuring alexithymia levels (higher score reflects higher alexithymia levels) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.
Neuroticism-Extraversion-Openness Five-Factor Inventory
时间窗: At baseline before the start of the measurement weeks
Self-report questionnaire measuring personality characteristics Neuroticism, Extraversion and Openness. The scores on these personality characteristics will be used as individual characteristics that are potential individual treatment markers in predicting the effectivity of the interventions.
Perseverative Cognition measured with daily Experience Sampling Methods
时间窗: 7 days, 10 times per day
Daily fluctuations in self-reported perseverative cognition using Experience Sampling Methods. The main outcome measure to assess perseverative cognition using Experience Sampling Measurement is the item asking whether participants are currently ruminating. An increase in rumination scores would indicate an increase in perseverative cognition.
Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.
时间窗: 24 hours
Physiological correlates of perseverative cognition measured as heart rate, measured with electrocardiogram.
Childhood Trauma Questionnaire-Short Form
时间窗: At baseline before the start of the measurement weeks
Self-report questionnaire measuring childhood trauma (higher score reflects higher childhood trauma levels) as an individual characteristic that are potential individual treatment markers in predicting the effectivity of the interventions.
Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task.
时间窗: 40 minutes task performance while measuring electroencephalogram
Electrophysiological correlates of perseverative cognition measured using electroencephalogram (EEG) during performance of a Sustained Attention to Response Task. The Sustained Attention to Response Task is a Go/No-Go Task interrupted by thought probes asking participants about the content and characteristics of their current thoughts. While performing the task, EEG is measured. To measure the neurophysiological correlates of perseverative cognition, EEG voltage when participants reported perseverative cognition on the Sustained Attention to Response Task will be examined and and compared with the EEG voltage when participants did not report perseverative cognition.
Leiden Index of Depression Sensitivity
时间窗: At baseline before the start of the measurement weeks
Self-report questionnaire measuring cognitive reactivity to sadness (higher score reflects higher cognitive reactivity) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.
次要结局
- Inventory of Depressive Symptomatology(Measured on day 7 at the end of each measurement week.)
- Emotion Regulation Questionnaire(Measured on day 7 at the end of each measurement week.)
- Five Facet Mindfulness Questionnaire(Measured on day 7 at the end of each measurement week.)
- Leuven Adaptation of the Rumination on Sadness Scale(Measured on day 7 at the end of each measurement week.)
- Positive and Negative Affect Schedule(Measured on day 7 at the end of each measurement week.)
- Sleep as measured with Actigraphy(7 days)
- Perseverative Thinking Questionnaire(Measured on day 7 at the end of each measurement week.)
- Responses on Positive Affect Scale(Measured on day 7 at the end of each measurement week.)