Actively Recruiting
Promoting Resilience in Youth Through Mindfulness mEditation
Led by Radboud University Medical Center · Updated on 2024-12-13
155
Participants Needed
2
Research Sites
155 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
D
Donders Centre for Cognitive Neuroimaging
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this randomized controlled trial (RCT) is to assess whether mindfulness training reduces early stage internalizing problems such as anxiety, worrying, and low mood in help-seeking youth. Participants will be randomly assigned to one of two groups: 1) mindfulness + care-as-usual (CAU) or 2) CAU-only. The mindfulness program was developed specifically for youth with internalizing problems. The 8-week training program consists of weekly 2-hour sessions, with mindfulness, yoga, and mindful active movement in each session. In addition, participants are invited to practice at home in between sessions for around 20 minutes per day. Data will be collected at baseline (T0), end-of-treatment (T1) (or 2-3 months after baseline for the CAU-only group), and at 2 months follow-up (T2) and 6 months follow-up (T3). Measurements will include: * Self-report questionnaires (T0, T1, T2, T3) * Psychiatric diagnostic interview (T0, T3) * MRI scans (T0, T1) * Cognitive tasks (T0, T1) The primary outcome parameter is the total number of internalizing problems measured with the Adult Self Report (ASR) at end-of-treatment. The effect of mindfulness training (mindfulness + CAU vs. CAU-only) on internalizing problems at T1 will be assessed using a linear-mixed effects model.
CONDITIONS
Official Title
Promoting Resilience in Youth Through Mindfulness mEditation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth between 16 and 25 years of age
- Provide written informed consent
- Adequate mastery of Dutch language
You will not qualify if you...
- Lifetime diagnosis of severe major depression, bipolar disorder, schizophrenia spectrum disorder, personality disorder, or post-traumatic stress disorder
- History of major medical illness or neurological illness
- Participation in a mindfulness programme in the past year
- Current participation in another intervention study
- Moderate to severe substance use disorders (mild substance use allowed)
- Current active suicidality, psychotic symptoms above clinical cut-off, or trauma-related complaints above clinical cut-off for PTSD
- Diagnosed or suspected mild intellectual disability (estimated IQ below 75)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Radboud university medical center (Radboudumc)
Nijmegen, Gelderland, Netherlands, 6500 HB
Actively Recruiting
2
Donders Centre for Cognitive Neuroimaging (DCCN)
Nijmegen, Gelderland, Netherlands, 6525 EN
Active, Not Recruiting
Research Team
G
Guusje Collin, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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