Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression

NCT06145984 | Unknown DMC

• 1 other identifier: 2019/537
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression in Remission

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Inventory of Depressive Symptomatology

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

• Perseverative Thinking Questionnaire

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

• Responses on Positive Affect Scale

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

• Emotion Regulation Questionnaire

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

• Five Facet Mindfulness Questionnaire

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

Study Arms (2)

Mindfulness first intervention, Fantasizing second intervention

OTHER

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.

Behavioral: Mindfulness; Behavioral: Positive Fantasizing

Fantasizing first intervention, Mindfulness second intervention

OTHER

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.

Behavioral: Mindfulness; Behavioral: Positive Fantasizing

Interventions

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.

Fantasizing first intervention, Mindfulness second intervention; Mindfulness first intervention, Fantasizing second intervention

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.

Fantasizing first intervention, Mindfulness second intervention; Mindfulness first intervention, Fantasizing second intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• University of Groningen: collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 AV, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38373948 DERIVED

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Marie-José van Tol, professor

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-José van Tol, professor

CONTACT

+31503616405; m.j.van.tol@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 24, 2023
• Study Start: June 19, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

NL (1)