Status:
UNKNOWN
Mechanisms of Change of Positive Interventions in Reducing Vulnerability for Depression
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
University of Groningen
Netherlands Organisation for Scientific Research
Conditions:
Depression in Remission
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06145984
Start Date
June 19 2020
End Date
January 1 2024
Last Update
November 24 2023
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 AV