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Promoting Resilience in Youth Through Mindfulness mEditation
Sponsor: Radboud University Medical Center
Summary
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.
Official title: The PRYME Study: Promoting Resilience in Youth Through Mindfulness mEditation.
Key Details
Gender
All
Age Range
16 Years - 25 Years
Study Type
INTERVENTIONAL
Enrollment
155
Start Date
2023-07-07
Completion Date
2026-07-01
Last Updated
2024-12-13
Healthy Volunteers
No
Conditions
Interventions
Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training
The investigational treatment is the LOS training, which is an adaptation of two previously validated mindfulness-based programs: Mindfulness-Based Cognitive Therapy (MBCT) developed by Segal, Williams, and Teasdale (2002) and the Mindful2Work (M2W) program developed by de Bruin, Formsma, and Bögels (2018). The M2W program combines mindful physical activity, yoga, and mindfulness meditation to target stress symptoms and burn-out in adults. The LOS training was adapted from these programs to meet the needs of youth with internalizing problems. The training consists of 8 weekly 2-hour sessions that each comprise three elements: mindful physical activity (15-20 minutes), yoga (15-20 minutes), and mindfulness meditation exercises (80-90 minutes). In addition to attending group sessions, participants are invited to practice at home on a daily basis. Home practice consists of daily mindfulness practices comprising mindfulness exercises, yoga and mindful physical activity.
Care as usual
Youth who seek help for internalizing problems from a primary mental health practitioner, including student psychologists or mental health nurse practioners, but do not (yet) meet criteria for (major) mental illness are typically offered supportive counselling, aimed primarily at helping people feel understood and supported. Supportive counselling may also include instructions on behavioral activation, particularly when individuals report reduced activity and behavioral avoidance including social withdrawal. In addition, mental health practitioners commonly employ a "watchful waiting" policy for people with symptoms in the milder range, where they check-in with clients on a regular basis and refer for more intensive treatment if and when symptoms worsen.
Locations (2)
Radboud university medical center (Radboudumc)
Nijmegen, Gelderland, Netherlands
Donders Centre for Cognitive Neuroimaging (DCCN)
Nijmegen, Gelderland, Netherlands