About this trial
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.
Eligibility criteria
Qualifiers
Youth between 16 and 25 years of age
Provide written informed consent
Adequate mastery of Dutch language
Disqualifiers
Lifetime diagnosis of severe major depression, bipolar disorder, schizophrenia spectrum disorder, personality disorder, and 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
Trial design
Treatments tested in this trial
- Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training
- Care as usual
Treatment groups
Sponsors and collaborators
Radboud University Medical Center
Lead sponsor
Donders Centre for Cognitive Neuroimaging
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Brain & Behavior Research Foundation
Collaborator