Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression (MINDCOG)
15 de junio de 2026 actualizado por: University Medical Center Groningen
Understanding Mechanisms of Prevention of Depression: a Mechanistic Cross-over Trial of Mindfulness vs. Fantasizing to Reduce Perseverative Cognition Underlying Vulnerability for Depression
The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marie-José van Tol, professor
- Número de teléfono: +31503616405
- Correo electrónico: m.j.van.tol@umcg.nl
Ubicaciones de estudio
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Provincie Groningen
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Groningen, Provincie Groningen, Países Bajos, 9713 AV
- Reclutamiento
- University Medical Center Groningen
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Contacto:
- Guus van den Brekel
- Número de teléfono: +3150 361 6194
- Correo electrónico: a.j.p.van.den.brekel@umcg.nl
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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.
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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 participants continue performing short exercises using the learned technique every day guided by an application on their smartphone customized for this research.
Specifically, participants perform one short exercise (10 min) per day for in total six days.
The exercises that are being performed are: attention to breathing part 1, attention to breathing part 2, attention to sounds, attention to bodily sensations, attention to thoughts, attention to emotions and feelings.
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 fantasy belief as if in an ideal world.
After using imagery techniques, participants are asked, with help of the professional, to reflect on their experience during the fantasizing exercise and to think of how they could implement this fantasy belief more in their daily life, by adapting their fantasy belief into a more practical belief.
After the training, participants are asked to perform one exercise per day using the fantasizing technique using a mobile application for six days in total.
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Otro: 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.
|
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 participants continue performing short exercises using the learned technique every day guided by an application on their smartphone customized for this research.
Specifically, participants perform one short exercise (10 min) per day for in total six days.
The exercises that are being performed are: attention to breathing part 1, attention to breathing part 2, attention to sounds, attention to bodily sensations, attention to thoughts, attention to emotions and feelings.
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 fantasy belief as if in an ideal world.
After using imagery techniques, participants are asked, with help of the professional, to reflect on their experience during the fantasizing exercise and to think of how they could implement this fantasy belief more in their daily life, by adapting their fantasy belief into a more practical belief.
After the training, participants are asked to perform one exercise per day using the fantasizing technique using a mobile application for six days in total.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perseverative Cognition measured with daily Experience Sampling Methods
Periodo de tiempo: 7 days, 10 times per day
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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.
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7 days, 10 times per day
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Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.
Periodo de tiempo: 24 hours
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Physiological correlates of perseverative cognition measured as heart rate, measured with electrocardiogram.
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24 hours
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Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram.
Periodo de tiempo: 24 hours
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Physiological correlates of perseverative cognition measure das heart rate variability measured with electrocardiogram
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24 hours
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Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task.
Periodo de tiempo: 40 minutes task performance while measuring electroencephalogram
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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.
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40 minutes task performance while measuring electroencephalogram
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Apathy Evaluation Scale
Periodo de tiempo: At baseline before the start of the measurement weeks
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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.
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At baseline before the start of the measurement weeks
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Bermond-Vorst Alexithymia Questionnaire
Periodo de tiempo: At baseline before the start of the measurement weeks
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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.
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At baseline before the start of the measurement weeks
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Leiden Index of Depression Sensitivity
Periodo de tiempo: At baseline before the start of the measurement weeks
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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.
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At baseline before the start of the measurement weeks
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Childhood Trauma Questionnaire-Short Form
Periodo de tiempo: At baseline before the start of the measurement weeks
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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.
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At baseline before the start of the measurement weeks
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Dysfunctional Attitude Scale
Periodo de tiempo: At baseline before the start of the measurement weeks
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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.
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At baseline before the start of the measurement weeks
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Neuroticism-Extraversion-Openness Five-Factor Inventory
Periodo de tiempo: At baseline before the start of the measurement weeks
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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.
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At baseline before the start of the measurement weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inventory of Depressive Symptomatology
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring depressive symptoms (higher scores reflect higher depressive symptoms)
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Measured on day 7 at the end of each measurement week.
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Perseverative Thinking Questionnaire
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring perseverative thinking (higher scores reflect higher levels of perseverative thinking)
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Measured on day 7 at the end of each measurement week.
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Responses on Positive Affect Scale
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring ruminative and dampening thoughts in response to positive affect (higher scores reflect higher rumination levels).
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Measured on day 7 at the end of each measurement week.
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Emotion Regulation Questionnaire
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring the emotion regulation strategies suppression and reappraisal (higher scores reflect using a particular strategy more).
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Measured on day 7 at the end of each measurement week.
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Five Facet Mindfulness Questionnaire
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring five facets of mindfulness: non-reactivity to inner experience, observing, acting with awareness, describing and non-judging of experience.
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Measured on day 7 at the end of each measurement week.
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Leuven Adaptation of the Rumination on Sadness Scale
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring ruminative thinking on sadness (higher scores reflect higher levels of ruminative thinking).
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Measured on day 7 at the end of each measurement week.
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Positive and Negative Affect Schedule
Periodo de tiempo: Measured on day 7 at the end of each measurement week.
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Self-report questionnaire measuring positive and negative affect (higher scores reflect higher levels of positive or negative affect).
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Measured on day 7 at the end of each measurement week.
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Sleep as measured with Actigraphy
Periodo de tiempo: 7 days
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Actigraphy is used as a measure of sleep-wake cycles, using the MotionWare 8.
This is a device that can measure activity counts and sleep using accelerometer data interpreted by software algorithms.
Actigraphy will be used to assess sleep efficacy during the measurement weeks.
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7 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marie-José van Tol, professor, University Medical Center Groningen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de junio de 2020
Finalización primaria (Estimado)
24 de septiembre de 2026
Finalización del estudio (Estimado)
24 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
9 de octubre de 2023
Primero enviado que cumplió con los criterios de control de calidad
16 de noviembre de 2023
Publicado por primera vez (Actual)
24 de noviembre de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2019/537
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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