Understanding how mindfulness and positive fantasizing can help reduce depression vulnerability

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

This study is testing if mindfulness and positive fantasizing can help people who have recovered from depression avoid falling back into it.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University Medical Center Groningen (other)
• Locations: 1 site (Groningen)
• Trial ID: NCT06145984 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 to 60 who have remitted from at least two major depressive episodes and are at high risk for relapse.

Not a fit: Patients who are currently experiencing significant depressive symptoms or have not had a history of depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new strategies for preventing relapse in individuals with a history of depression.

How similar studies have performed: Other studies have shown promising results using mindfulness and positive interventions for mental health, suggesting potential success for this approach.

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.

Where this trial is running

Groningen

• University Medical Center Groningen — Groningen, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Marie-José van Tol, professor — University Medical Center Groningen
• Study coordinator: Marie-José van Tol, professor

Conditions: Depression in Remission