Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression

Официальное название

Understanding Mechanisms of Prevention of Depression: a Mechanistic Cross-over Trial of Mindfulness vs. Fantasizing to Reduce Perseverative Cognition Underlying Vulnerability for Depression

Обзор

The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.

Подробное описание

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

Вмешательства

• Поведенческое Mindfulness
  Participants receive a two-hour professional training to get familiar with the basic techniques of mindfulness. The training is given by a mindfulness professional and consists of psycho-education, instructions for mindfulness and guided practice. It focuses mainly on attending to stimuli such as breathing, external sounds or bodily sensations and becoming aware of where one's attention is. After the professional training, participants receive instructions about the audio application with which
• Поведенческое Positive Fantasizing
  In a two-hour training session by a professional trainer, participants get familiar with the positive fantasizing technique. Participants receive psycho-education about the role of dysfunctional beliefs. The positive fantasizing technique starts with identifying dysfunctional "beliefs and schema" and subsequently fantasize about a positive "fantasy belief". Participants are guided by the professional using imagery and experiencing thoughts and feelings that would be elicited when using their fan

Первичные конечные точки

• Perseverative Cognition measured with daily Experience Sampling Methods [Срок оценки: 7 days, 10 times per day]
• Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram. [Срок оценки: 24 hours]
• Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram. [Срок оценки: 24 hours]
• Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task. [Срок оценки: 40 minutes task performance while measuring electroencephalogram]
• Apathy Evaluation Scale [Срок оценки: At baseline before the start of the measurement weeks]
• Bermond-Vorst Alexithymia Questionnaire [Срок оценки: At baseline before the start of the measurement weeks]
• Leiden Index of Depression Sensitivity [Срок оценки: At baseline before the start of the measurement weeks]
• Childhood Trauma Questionnaire-Short Form [Срок оценки: At baseline before the start of the measurement weeks]
• Dysfunctional Attitude Scale [Срок оценки: At baseline before the start of the measurement weeks]
• Neuroticism-Extraversion-Openness Five-Factor Inventory [Срок оценки: At baseline before the start of the measurement weeks]

Вторичные конечные точки (8)

• Inventory of Depressive Symptomatology [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Perseverative Thinking Questionnaire [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Responses on Positive Affect Scale [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Emotion Regulation Questionnaire [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Five Facet Mindfulness Questionnaire [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Leuven Adaptation of the Rumination on Sadness Scale [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Positive and Negative Affect Schedule [Срок оценки: Measured on day 7 at the end of each measurement week.]
• Sleep as measured with Actigraphy [Срок оценки: 7 days]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Нидерланды · 1 центр

• University Medical Center Groningen — Groningen

Публикации

• Besten ME, van Vugt M, Riese H, Bockting CLH, Ostafin BD, Aleman A, van Tol MJ. Understanding mechanisms of depression prevention: study protocol of a randomized cross-over trial to investigate mechanisms of mindfulness and positive fantasizing as intervention techniques for reducing perseverative cognition in remitted depressed individuals. BMC Psychiatry. 2024 Feb 19;24(1):141. doi: 10.1186/s128 PMID 38373948

Идентификаторы

NCT: NCT06145984 · 2019/537

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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