Understanding how mindfulness and positive fantasizing can help reduce depression vulnerability

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of mindfulness and positive fantasizing on reducing cognitive patterns that contribute to vulnerability for depression in individuals who have remitted from major depressive episodes. Using a cross-over design, participants will undergo both interventions while their thought patterns, behaviors, and physiological responses are measured through various assessments, including questionnaires and neurophysiological monitoring. The study aims to identify individual characteristics that may predict the effectiveness of these interventions in preventing depressive relapse.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Medical Center Groningen
  Groningen, Provincie Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: Marie-José van Tol, professor — University Medical Center Groningen
• Study coordinator: Marie-José van Tol, professor
• Email: m.j.van.tol@umcg.nl
• Phone: +31503616405

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.