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Depression in RemissionMINDCOGNCT06145984

Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression

A study testing Mindfulness and Positive Fantasizing in people with Depression in Remission, run by University Medical Center Groningen at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Depression in Remission
What is being tested?
Mindfulness and Positive Fantasizing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteNetherlands
Study dates
19 Jun 2020to 24 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marie-José van Tol, professor contact

+31503616405

m.j.van.tol@umcg.nl

Netherlands1 site, 1 recruiting
  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713 AV

    Guus van den Brekel, +3150 361 6194, a.j.p.van.den.brekel@umcg.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: 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.

Read the detailed description

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

Being tested
Mindfulness, Positive Fantasizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MindfulnessBehavioural

    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.

  • Positive FantasizingBehavioural

    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.

Study groups in NCT06145984
Study groupRoleWhat they receive
Mindfulness first intervention, Fantasizing second interventionOtherDiary 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.
Receives: Behavioral: Mindfulness; Behavioral: Positive Fantasizing
Fantasizing first intervention, Mindfulness second interventionOtherDiary 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.
Receives: Behavioral: Mindfulness; Behavioral: Positive Fantasizing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perseverative Cognition measured with daily Experience Sampling Methods

    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.

    Measured: 7 days, 10 times per day

  2. Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.

    Physiological correlates of perseverative cognition measured as heart rate, measured with electrocardiogram.

    Measured: 24 hours

  3. Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram.

    Physiological correlates of perseverative cognition measure das heart rate variability measured with electrocardiogram

    Measured: 24 hours

  4. Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task.

    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.

    Measured: 40 minutes task performance while measuring electroencephalogram

  5. Apathy Evaluation Scale

    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.

    Measured: At baseline before the start of the measurement weeks

  6. Bermond-Vorst Alexithymia Questionnaire

    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.

    Measured: At baseline before the start of the measurement weeks

  7. Leiden Index of Depression Sensitivity

    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.

    Measured: At baseline before the start of the measurement weeks

  8. Childhood Trauma Questionnaire-Short Form

    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.

    Measured: At baseline before the start of the measurement weeks

  9. Dysfunctional Attitude Scale

    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.

    Measured: At baseline before the start of the measurement weeks

  10. Neuroticism-Extraversion-Openness Five-Factor Inventory

    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.

    Measured: At baseline before the start of the measurement weeks

Secondary outcomes (8)
  1. Inventory of Depressive Symptomatology

    Self-report questionnaire measuring depressive symptoms (higher scores reflect higher depressive symptoms)

    Measured: Measured on day 7 at the end of each measurement week.

  2. Perseverative Thinking Questionnaire

    Self-report questionnaire measuring perseverative thinking (higher scores reflect higher levels of perseverative thinking)

    Measured: Measured on day 7 at the end of each measurement week.

  3. Responses on Positive Affect Scale

    Self-report questionnaire measuring ruminative and dampening thoughts in response to positive affect (higher scores reflect higher rumination levels).

    Measured: Measured on day 7 at the end of each measurement week.

  4. Emotion Regulation Questionnaire

    Self-report questionnaire measuring the emotion regulation strategies suppression and reappraisal (higher scores reflect using a particular strategy more).

    Measured: Measured on day 7 at the end of each measurement week.

  5. Five Facet Mindfulness Questionnaire

    Self-report questionnaire measuring five facets of mindfulness: non-reactivity to inner experience, observing, acting with awareness, describing and non-judging of experience.

    Measured: Measured on day 7 at the end of each measurement week.

  6. Leuven Adaptation of the Rumination on Sadness Scale

    Self-report questionnaire measuring ruminative thinking on sadness (higher scores reflect higher levels of ruminative thinking).

    Measured: Measured on day 7 at the end of each measurement week.

  7. Positive and Negative Affect Schedule

    Self-report questionnaire measuring positive and negative affect (higher scores reflect higher levels of positive or negative affect).

    Measured: Measured on day 7 at the end of each measurement week.

  8. Sleep as measured with Actigraphy

    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.

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2023
  2. Study start19 Jun 2020
  3. Primary completion24 Sep 2026 (estimated)
  4. Study completion24 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06145984
Sponsor's protocol ID
2019/537
Acronym
MINDCOG
Status last verified
Jun 2026
First submitted
9 Oct 2023
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38373948

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness and Positive Fantasizing in people with Depression in Remission, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie-José van Tol, professor (+31503616405, m.j.van.tol@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perseverative Cognition measured with daily Experience Sampling Methods (time frame: 7 days, 10 times per day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06145984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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