Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Medical Center Groningen

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Mindfulness

    Behavioral

    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

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Mindfulness first intervention, Fantasizing second interventionOther 2 interventions
Group B: Fantasizing first intervention, Mindfulness second interventionOther 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days, 10 times per day
2

Physiological correlates of perseverative cognition using heart rate measured with electrocardiogram.

Physiological correlates of perseverative cognition measured as heart rate, measured with electrocardiogram.

Time frame
24 hours
3

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

Time frame
24 hours
4

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.

Time frame
40 minutes task performance while measuring electroencephalogram

Secondary outcomes

1

Inventory of Depressive Symptomatology

Self-report questionnaire measuring depressive symptoms (higher scores reflect higher depressive symptoms)

Time frame
Measured on day 7 at the end of each measurement week.
2

Perseverative Thinking Questionnaire

Self-report questionnaire measuring perseverative thinking (higher scores reflect higher levels of perseverative thinking)

Time frame
Measured on day 7 at the end of each measurement week.
3

Responses on Positive Affect Scale

Self-report questionnaire measuring ruminative and dampening thoughts in response to positive affect (higher scores reflect higher rumination levels).

Time frame
Measured on day 7 at the end of each measurement week.
4

Emotion Regulation Questionnaire

Self-report questionnaire measuring the emotion regulation strategies suppression and reappraisal (higher scores reflect using a particular strategy more).

Time frame
Measured on day 7 at the end of each measurement week.

Other outcomes

Sponsors and contacts

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University Medical Center Groningen

Lead sponsor

University of Groningen

Collaborator

Netherlands Organisation for Scientific Research

Collaborator