Predicting and Understanding Depression Prevention Techniques: a mechanistic cross-over trial of mindfulness vs. fantasizing to reduce vulnerability for depressio
- Conditions
- major depressive disorder
- Registration Number
- NL-OMON22588
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
In order to be eligible to participate in this study, a participant must meet all the following criteria:
-Participants should be between 18 and 60 years old. They should not exceed 60 years of age in order to avoid aging related pathology in information processing (Salthouse, 2010);
-Participants should display normal intelligence (IQ>85, as assessed with the Dutch Adult Reading Test (DART; Schmand et al., 1991) and/or having finished an education on at least vocational level).
In order to be eligible to participate in the patient group of the study, a patient participant must additionally meet all the following criteria:
-Participating patients should be in (partial or complete) remission from an Major Depressive episode for more than two months, criteria defined by the Diagnostic Statistical Manual, version 5;
-Patients should have experienced at least two depressive episodes, criteria defined by the Diagnostic Statistical Manual, version 5, experienced in past ten years;
-Patients should score 21 or lower on the Inventory of Depressive Symptomatology (IDS-SR30), indicative of the absence of clinically relevant depressive symptoms (Rush et al., 2000).
A potential participant who meets any of the following criteria will be excluded from participation in this study:
-Participants with any current DSM-5 diagnoses as objectified with the SCID-I;
-Daily use of anti-depressant medication, benzodiazepines, methylphenidate, beta blockers or other medication potentially influencing ICG/ECG currently or in the last four weeks;
-Participants who recently (defined as their last episode, or as one year prior to inclusion in case the last episode was more than a year before inclusion) received the preventive cognitive therapy including the positive fantasizing technique and/or have recent experiences (defined as daily practice in mindfulness in the past two years for at least two weeks) with mindfulness, meditation or mindful yoga. This will be done to prevent overestimation of true effects of mindfulness and/or positive fantasizing;
-Participants who participate in another clinical intervention study at the moment of inclusion in the study.
A potential participant for the HC group who meets 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);
-Any life-time psychopathology of any disorder as objectified with the SCID-I.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Main endpoint: Pre- and peri-intervention changes between-groups (MDD vs. HC) and within-subjects (mindfulness vs. fantasizing) in 1) self-reported measures of PC measured with ESM and the SART; 2) HR, HRV and PEP during reported PC and sleep; 3) EEG characteristics during PC measured with the SART.<br><br>Main endpoint: Correlations between individual differences in pre-intervention measures of personal characteristics (i.e. pre-intervention main parameters) and the efficacy of mindfulness vs. fantasizing (i.e. changes in pre- and peri-intervention main parameters).<br>
- Secondary Outcome Measures
Name Time Method Secondary parameters concern: i) measures of depressive symptoms and other factors that are potent in being influenced by the interventions (measured with self-report questionnaires: IDS-SR [depressive symptomology], FFMQ [mindfulness], PANAS [positive and negative affect states], LARSS [ruminative thinking on sadness], ERQ [emotion regulation strategies], RPA-NL [ruminative thought in response to positive affect], PTQ [perseverative thinking]; see 6.3.5 Pre- and peri-intervention measurements materials [T1-T4]); ii) actigraphy measures reflecting sleep patterns and iii) indices of PC as measured with self-report questions, EEG and ICG/ECG (see 6.3.5 Pre- and peri-intervention measurements materials [T1-T4]). These parameters are measured pre- and peri-interventions and will be compared to study intervention effects.