Promoting Resilience in Youth Through Mindfulness mEditation

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.

Conditions

• Internalizing Problems

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Donders Centre for Cognitive Neuroimaging

  collaborator OTHER

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• Brain & Behavior Research Foundation

  collaborator OTHER

• Radboud University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-07

Primary Completion

2026-01-01

Completion

2026-07-01

Countries

• Netherlands

Study Locations