Mindfulness og Positive Fantasizing i Depression i remission - Kliniske forsøgsregister

Studieoversigt

Status

Rekruttering

Betingelser

Depression i remission

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Marie-José van Tol, professor
Telefonnummer: +31503616405
E-mail: m.j.van.tol@umcg.nl

Studiesteder

Holland
- Provincie Groningen
  - Groningen, Provincie Groningen, Holland, 9713 AV
    - Rekruttering
    - University Medical Center Groningen
    - Kontakt:
      
      Guus van den Brekel
      
      Telefonnummer: +3150 361 6194
      
      E-mail: a.j.p.van.den.brekel@umcg.nl

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Andet
Tildeling: Randomiseret
Interventionel model: Crossover opgave
Maskning: Ingen (Åben etiket)

Antal våben

2

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Andet: 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.	Adfærdsmæssigt: 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 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. Adfærdsmæssigt: 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 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.
Andet: 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.	Adfærdsmæssigt: 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 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. Adfærdsmæssigt: 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 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.

Deltagergruppe / Arm

Intervention / Behandling

Andet: 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.

Adfærdsmæssigt: 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 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.

Adfærdsmæssigt: 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 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.

Andet: 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.

Adfærdsmæssigt: 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 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.

Adfærdsmæssigt: 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 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Inventory of Depressive Symptomatology Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring depressive symptoms (higher scores reflect higher depressive symptoms)	Measured on day 7 at the end of each measurement week.
Perseverative Thinking Questionnaire Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring perseverative thinking (higher scores reflect higher levels of perseverative thinking)	Measured on day 7 at the end of each measurement week.
Responses on Positive Affect Scale Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring ruminative and dampening thoughts in response to positive affect (higher scores reflect higher rumination levels).	Measured on day 7 at the end of each measurement week.
Emotion Regulation Questionnaire Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring the emotion regulation strategies suppression and reappraisal (higher scores reflect using a particular strategy more).	Measured on day 7 at the end of each measurement week.
Five Facet Mindfulness Questionnaire Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring five facets of mindfulness: non-reactivity to inner experience, observing, acting with awareness, describing and non-judging of experience.	Measured on day 7 at the end of each measurement week.
Leuven Adaptation of the Rumination on Sadness Scale Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring ruminative thinking on sadness (higher scores reflect higher levels of ruminative thinking).	Measured on day 7 at the end of each measurement week.
Positive and Negative Affect Schedule Tidsramme: Measured on day 7 at the end of each measurement week.	Self-report questionnaire measuring positive and negative affect (higher scores reflect higher levels of positive or negative affect).	Measured on day 7 at the end of each measurement week.
Sleep as measured with Actigraphy Tidsramme: 7 days	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.	7 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Medical Center Groningen

Samarbejdspartnere

University of Groningen

Netherlands Organisation for Scientific Research

Efterforskere

Ledende efterforsker: Marie-José van Tol, professor, University Medical Center Groningen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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/s12888-024-05592-8.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. juni 2020

Primær færdiggørelse (Anslået)

24. september 2026

Studieafslutning (Anslået)

24. september 2026

Datoer for studieregistrering

Først indsendt

9. oktober 2023

Først indsendt, der opfyldte QC-kriterier

16. november 2023

Først opslået (Faktiske)

24. november 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

2019/537

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression (MINDCOG)

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Anslået)

Fase

Kontakter og lokationer

Studiekontakt

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Anslået)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Kliniske forsøg med Depression i remission

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Zimbabwe

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

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