NCT06145984 Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression
| NCT ID | NCT06145984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Depression in Remission |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2020-06-19 |
| Primary Completion | 2026-09-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2020-06-19 with a primary completion date of 2026-09-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.
Eligibility Criteria
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.
Contact & Investigator
Marie-José van Tol, professor
PRINCIPAL INVESTIGATOR
University Medical Center Groningen
Frequently Asked Questions
Who can join the NCT06145984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Depression in Remission. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06145984 currently recruiting?
Yes, NCT06145984 is actively recruiting participants. Contact the research team at m.j.van.tol@umcg.nl for enrollment information.
Where is the NCT06145984 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06145984 clinical trial?
NCT06145984 is sponsored by University Medical Center Groningen. The principal investigator is Marie-José van Tol, professor at University Medical Center Groningen. The trial plans to enroll 100 participants.
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