Clinical trial NCT06145984: Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression in Remission
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: University of Groningen
name: Netherlands Organisation for Scientific Research
First posted: 2023-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to understand the effects of mindfulness and fantasizing in reducing perseverative cognition underlying vulnerability for depression.

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

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.

Primary outcomes:
measure: Perseverative Cognition measured with daily Experience Sampling Methods
timeFrame: 7 days, 10 times per day
measure: Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.
timeFrame: 24 hours
measure: Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram.
timeFrame: 24 hours
measure: Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task.
timeFrame: 40 minutes task performance while measuring electroencephalogram
measure: Apathy Evaluation Scale
timeFrame: At baseline before the start of the measurement weeks
measure: Bermond-Vorst Alexithymia Questionnaire
timeFrame: At baseline before the start of the measurement weeks
measure: Leiden Index of Depression Sensitivity
timeFrame: At baseline before the start of the measurement weeks
measure: Childhood Trauma Questionnaire-Short Form
timeFrame: At baseline before the start of the measurement weeks
measure: Dysfunctional Attitude Scale
timeFrame: At baseline before the start of the measurement weeks
measure: Neuroticism-Extraversion-Openness Five-Factor Inventory
timeFrame: At baseline before the start of the measurement weeks
Secondary outcomes:
measure: Inventory of Depressive Symptomatology
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Perseverative Thinking Questionnaire
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Responses on Positive Affect Scale
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Emotion Regulation Questionnaire
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Five Facet Mindfulness Questionnaire
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Leuven Adaptation of the Rumination on Sadness Scale
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Positive and Negative Affect Schedule
timeFrame: Measured on day 7 at the end of each measurement week.
measure: Sleep as measured with Actigraphy
timeFrame: 7 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Marie-José van Tol, professor
role: PRINCIPAL_INVESTIGATOR
References: