Mindfulness training to help youth with anxiety and low mood
The PRYME Study: Promoting Resilience in Youth Through Mindfulness mEditation.
This study is testing if an 8-week mindfulness training program can help young people aged 16 to 25 who are feeling anxious or low by teaching them mindfulness practices along with their usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 16 Years to 25 Years |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Nijmegen, Gelderland and 1 other locations) |
| Trial ID | NCT05916651 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of an 8-week mindfulness training program in reducing internalizing problems such as anxiety, worrying, and low mood in help-seeking youth aged 16 to 25. Participants will be divided into two groups: one receiving mindfulness training alongside standard care and the other receiving standard care only. The program includes weekly sessions featuring mindfulness practices, yoga, and active movement, with additional home practice encouraged. Data will be collected through self-report questionnaires, psychiatric interviews, MRI scans, and cognitive tasks at various time points throughout the study.
Who should consider this trial
Good fit: Ideal candidates are youth aged 16 to 25 who are seeking help for mild internalizing problems and can communicate effectively in Dutch.
Not a fit: Patients with severe mental health disorders or significant substance use issues may not benefit from this mindfulness intervention.
Why it matters
Potential benefit: If successful, this program could significantly reduce anxiety and depressive symptoms in youth, promoting better mental health outcomes.
How similar studies have performed: Previous studies have shown that mindfulness training can be effective in treating various mental health issues, suggesting a promising approach for this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Youth between 16 and 25 years of age 2. Provide written informed consent 3. Adequate mastery of Dutch language Exclusion Criteria: 1. Lifetime diagnosis of severe major depression, bipolar disorder, schizophrenia spectrum disorder, personality disorder, and post-traumatic stress disorder 2. History of major medical illness or neurological illness 3. Participation in a mindfulness programme in the past year 4. Current participation in another intervention study 5. Moderate to severe substance use disorders (i.e., we will allow for mild substance use) 6. Current active suicidality, current psychotic symptoms above clinical cut-off for psychosis, or current trauma-related complaints above clinical cut-off for PTSD. 7. Diagnosed or suspected (mild) intellectual disability (estimated IQ \< 75)
Where this trial is running
Nijmegen, Gelderland and 1 other locations
- Radboud university medical center (Radboudumc) — Nijmegen, Gelderland, Netherlands (Recruiting)
- Donders Centre for Cognitive Neuroimaging (DCCN) — Nijmegen, Gelderland, Netherlands (Active_not_recruiting)
Study contacts
- Study coordinator: Guusje Collin, MD, PhD
- Email: guusje.collin@radboudumc.nl
- Phone: +31 24 30 98988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.