Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression (NCT06145984) | Clinical Trial Compass
RecruitingNot Applicable
Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression
Netherlands100 participantsStarted 2020-06-19
Plain-language summary
The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Perseverative Cognition measured with daily Experience Sampling Methods
Timeframe: 7 days, 10 times per day
2
Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.
Timeframe: 24 hours
3
Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram.
Timeframe: 24 hours
4
Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task.
Timeframe: 40 minutes task performance while measuring electroencephalogram
5
Apathy Evaluation Scale
Timeframe: At baseline before the start of the measurement weeks
6
Bermond-Vorst Alexithymia Questionnaire
Timeframe: At baseline before the start of the measurement weeks