Psychological Distress Clinical Trial
Official title:
Changes in Cognitive and Emotional Patterns Associated to Meditation and Compassion Training: Attentional Changes and Network Dynamics
NCT number | NCT03920241 |
Other study ID # | PSI-559959-R |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | December 15, 2020 |
Verified date | May 2022 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study is aimed at comparing the differential effects of two widely used standardized meditation programs: Mindfulness-Based Stress Reduction (MBSR) and Compassion Cultivation Training (CCT) in general population samples. To address this goal, the effects will be measured by self-report questionnaires belonging to different domains (mindfulness, compassion, well-being, psychological distress, and psychological functioning) as well as information processing measures (i.e., Attentional Blink), and psychophysiological measures (EEG and EKG). Changes will be assessed immediately after finishing the 8-week programs and through several inter-session assessments. Data analysis will include the mean change scores differences, as well as novel network analysis procedures to assess topological reorganization of constructs derived from the programs.
Status | Completed |
Enrollment | 650 |
Est. completion date | December 15, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or more - Fluency in oral and written Spanish Exclusion Criteria: - Having any current of serious psychological disorder or substance abuse / dependence. - Being currently enrolled in another standardized meditation program |
Country | Name | City | State |
---|---|---|---|
Spain | School of Psychology | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20. Review. — View Citation
Kuyken W, Warren FC, Taylor RS, Whalley B, Crane C, Bondolfi G, Hayes R, Huijbers M, Ma H, Schweizer S, Segal Z, Speckens A, Teasdale JD, Van Heeringen K, Williams M, Byford S, Byng R, Dalgleish T. Efficacy of Mindfulness-Based Cognitive Therapy in Prevention of Depressive Relapse: An Individual Patient Data Meta-analysis From Randomized Trials. JAMA Psychiatry. 2016 Jun 1;73(6):565-74. doi: 10.1001/jamapsychiatry.2016.0076. — View Citation
Malinowski P. Neural mechanisms of attentional control in mindfulness meditation. Front Neurosci. 2013 Feb 4;7:8. doi: 10.3389/fnins.2013.00008. eCollection 2013. — View Citation
Tang YY, Leve LD. A translational neuroscience perspective on mindfulness meditation as a prevention strategy. Transl Behav Med. 2016 Mar;6(1):63-72. doi: 10.1007/s13142-015-0360-x. Review. — View Citation
van der Velden AM, Roepstorff A. Neural mechanisms of mindfulness meditation: bridging clinical and neuroscience investigations. Nat Rev Neurosci. 2015 Jul;16(7):439. doi: 10.1038/nrn3916-c1. Epub 2015 Jun 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in attention performance (Lab measures) | Attentional blink (accuracy emotion identification) | Pre- and post-intervention assessments (baseline and 8 weeks later) | |
Primary | Change from Baseline in brain activity (Lab measures) | EEG (frontal lobe activity) | Pre- and post-intervention assessments (baseline and 8 weeks later) | |
Primary | Change from Baseline in heart activity (Lab measures) | EKG (Heart rate variability) | Pre- and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Mindfulness - General mindfulness | Five-Facet Mindfulness Questionnaire (FFMQ) | Pre and post-intervention assessments as well as intersession assessments (8 weekly assessments) | |
Secondary | Mindfulness - Non-attachment | Non-Attachment Scale (NAS) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program)) | |
Secondary | Mindfulness - Decentering | Experiences Questionnaire (EQ) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Mindfulness - Interoceptive awareness | Multidimensional assessment of interoceptive awareness (MAIA) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Mindfulness - State mindfulness | State Mindfulness Scale (SMS) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Compassion - Self-compassion | Self-Compassion Scale (SCS) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Compassion - Compassion to others | Compassion Scale (CS) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Compassion - Empathy | Interpersonal Reactivity Index (IRI) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Compassion - State-compassion | Self-Compassion Scale-State (SCS_S) | Pre and post-intervention assessments as well as intersession assessments (weekly assessments during the 8 weeks of duration of the program) | |
Secondary | Psychological well-being - General well-being | Pemberton Happiness Index (PHI) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Psychological well-being - Satisfaction with life | Satisfaction With Life Scale (SWLS) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Psychological well-being - Optimism | Life Orientation Test-Revised (LOT-R) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Psychological distress - feelings of depression, anxiety and stress | Depression Anxiety Stress Scales (DASS-21) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Emotional and cognitive control - Rumination | Ruminative Response Style (RRS) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Emotional and cognitive control - thought suppression | White Bear Suppression Inventory (WBSI) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Emotional and cognitive control - Attentional control | Attentional Control Scale (ACS) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Emotional and cognitive control - Emotion regulation | Emotion Regulation Questionnaire (ERQ) | Pre and post-intervention assessments (baseline and 8 weeks later) | |
Secondary | Emotional and cognitive control - Emotional States | Emotional State Scale (ESS) | Pre and post-intervention assessments (baseline and 8 weeks later) |
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