Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression
NCT ID: NCT06145984
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2020-06-19
2024-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Mindfulness first intervention, Fantasizing second intervention
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. In this arm mindfulness will be the first performed intervention, fantasizing the second performed intervention. The order of the interventions will be counterbalanced across participants.
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.
Fantasizing first intervention, Mindfulness second intervention
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. In this arm fantasizing will be the first performed intervention, mindfulness the second performed intervention. The order of the interventions will be counterbalanced across participants.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University of Groningen
OTHER
Netherlands Organisation for Scientific Research
OTHER_GOV
University Medical Center Groningen
OTHER
Responsible Party
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Principal Investigators
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Marie-José van Tol, professor
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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University Medical Center Groningen
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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Besten ME, van Vugt M, Riese H, Bockting CLH, Ostafin BD, Aleman A, van Tol MJ. Understanding mechanisms of depression prevention: study protocol of a randomized cross-over trial to investigate mechanisms of mindfulness and positive fantasizing as intervention techniques for reducing perseverative cognition in remitted depressed individuals. BMC Psychiatry. 2024 Feb 19;24(1):141. doi: 10.1186/s12888-024-05592-8.
Other Identifiers
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2019/537
Identifier Type: -
Identifier Source: org_study_id