Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression

Depression in Remission Clinical Trial

— MINDCOG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06145984
• Other study ID #: 2019/537
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: University Medical Center Groningen
• Contact: Marie-José van Tol, professor
• Phone: +31503616405
• Email: m.j.van.tol[@]umcg.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression in Remission
• Depressive Disorder

Intervention

Behavioral:
• Mindfulness
Participants receive a two-hour professional training to get familiar with the basic techniques of mindfulness. The training is given by a mindfulness professional and consists of psycho-education, instructions for mindfulness and guided practice. It focuses mainly on attending to stimuli such as breathing, external sounds or bodily sensations and becoming aware of where one's attention is. After the professional training, participants receive instructions about the audio application with which participants continue performing short exercises using the learned technique every day guided by an application on their smartphone customized for this research. Specifically, participants perform one short exercise (10 min) per day for in total six days. The exercises that are being performed are: attention to breathing part 1, attention to breathing part 2, attention to sounds, attention to bodily sensations, attention to thoughts, attention to emotions and feelings.
• Positive Fantasizing
In a two-hour training session by a professional trainer, participants get familiar with the positive fantasizing technique. Participants receive psycho-education about the role of dysfunctional beliefs. The positive fantasizing technique starts with identifying dysfunctional "beliefs and schema" and subsequently fantasize about a positive "fantasy belief". Participants are guided by the professional using imagery and experiencing thoughts and feelings that would be elicited when using their fantasy belief as if in an ideal world. After using imagery techniques, participants are asked, with help of the professional, to reflect on their experience during the fantasizing exercise and to think of how they could implement this fantasy belief more in their daily life, by adapting their fantasy belief into a more practical belief. After the training, participants are asked to perform one exercise per day using the fantasizing technique using a mobile application for six days in total.

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	Netherlands Organisation for Scientific Research, University of Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perseverative Cognition measured with daily Experience Sampling Methods	Daily fluctuations in self-reported perseverative cognition using Experience Sampling Methods. The main outcome measure to assess perseverative cognition using Experience Sampling Measurement is the item asking whether participants are currently ruminating. An increase in rumination scores would indicate an increase in perseverative cognition.	7 days, 10 times per day
Primary	Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.	Physiological correlates of perseverative cognition measured as heart rate, measured with electrocardiogram.	24 hours
Primary	Physiological correlates of perseverative cognition using heart rate variability measured with electrocardiogram.	Physiological correlates of perseverative cognition measure das heart rate variability measured with electrocardiogram	24 hours
Primary	Neurophysiological correlates of perseverative cognition using electroencephalogram during performance of the Sustained Attention to Response Task.	Electrophysiological correlates of perseverative cognition measured using electroencephalogram (EEG) during performance of a Sustained Attention to Response Task. The Sustained Attention to Response Task is a Go/No-Go Task interrupted by thought probes asking participants about the content and characteristics of their current thoughts. While performing the task, EEG is measured. To measure the neurophysiological correlates of perseverative cognition, EEG voltage when participants reported perseverative cognition on the Sustained Attention to Response Task will be examined and and compared with the EEG voltage when participants did not report perseverative cognition.	40 minutes task performance while measuring electroencephalogram
Primary	Apathy Evaluation Scale	Self-report questionnaire measuring apathy levels (higher score reflects higher apathy levels) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.	At baseline before the start of the measurement weeks
Primary	Bermond-Vorst Alexithymia Questionnaire	Self-report questionnaire measuring alexithymia levels (higher score reflects higher alexithymia levels) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.	At baseline before the start of the measurement weeks
Primary	Leiden Index of Depression Sensitivity	Self-report questionnaire measuring cognitive reactivity to sadness (higher score reflects higher cognitive reactivity) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.	At baseline before the start of the measurement weeks
Primary	Childhood Trauma Questionnaire-Short Form	Self-report questionnaire measuring childhood trauma (higher score reflects higher childhood trauma levels) as an individual characteristic that are potential individual treatment markers in predicting the effectivity of the interventions.	At baseline before the start of the measurement weeks
Primary	Dysfunctional Attitude Scale	Self-report questionnaire measuring dysfunctional attitudes (higher score reflects higher dysfunctional attitudes) examined as an individual characteristic that could be a potential individual treatment marker in predicting the effectivity of the interventions.	At baseline before the start of the measurement weeks
Primary	Neuroticism-Extraversion-Openness Five-Factor Inventory	Self-report questionnaire measuring personality characteristics Neuroticism, Extraversion and Openness. The scores on these personality characteristics will be used as individual characteristics that are potential individual treatment markers in predicting the effectivity of the interventions.	At baseline before the start of the measurement weeks
Secondary	Inventory of Depressive Symptomatology	Self-report questionnaire measuring depressive symptoms (higher scores reflect higher depressive symptoms)	Measured on day 7 at the end of each measurement week.
Secondary	Perseverative Thinking Questionnaire	Self-report questionnaire measuring perseverative thinking (higher scores reflect higher levels of perseverative thinking)	Measured on day 7 at the end of each measurement week.
Secondary	Responses on Positive Affect Scale	Self-report questionnaire measuring ruminative and dampening thoughts in response to positive affect (higher scores reflect higher rumination levels).	Measured on day 7 at the end of each measurement week.
Secondary	Emotion Regulation Questionnaire	Self-report questionnaire measuring the emotion regulation strategies suppression and reappraisal (higher scores reflect using a particular strategy more).	Measured on day 7 at the end of each measurement week.
Secondary	Five Facet Mindfulness Questionnaire	Self-report questionnaire measuring five facets of mindfulness: non-reactivity to inner experience, observing, acting with awareness, describing and non-judging of experience.	Measured on day 7 at the end of each measurement week.
Secondary	Leuven Adaptation of the Rumination on Sadness Scale	Self-report questionnaire measuring ruminative thinking on sadness (higher scores reflect higher levels of ruminative thinking).	Measured on day 7 at the end of each measurement week.
Secondary	Positive and Negative Affect Schedule	Self-report questionnaire measuring positive and negative affect (higher scores reflect higher levels of positive or negative affect).	Measured on day 7 at the end of each measurement week.
Secondary	Sleep as measured with Actigraphy	Actigraphy is used as a measure of sleep-wake cycles, using the MotionWare 8. This is a device that can measure activity counts and sleep using accelerometer data interpreted by software algorithms. Actigraphy will be used to assess sleep efficacy during the measurement weeks.	7 days