Promoting Resilience in Youth Through Mindfulness mEditation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-25
SponsorRadboud University Medical Center

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

155 Participants
are divided into 2 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