NCT05916651: PRYME

Promoting Resilience in Youth Through Mindfulness mEditation

Recruiting now NA Last updated 13 December 2024

What this trial tests

NA trial testing Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training in Internalizing Problems in 155 participants. Currently enrolling.

Timeline

7 July 2023

Primary endpoint
1 January 2026

1 July 2026

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	155
Start date	7 July 2023
Primary completion	1 January 2026
Estimated completion	1 July 2026
Sites	2 locations across Netherlands

Drugs / interventions tested

• Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training
• Care as usual — full drug profile →

Conditions studied

• Internalizing Problems — all drugs for Internalizing Problems →

Sponsor

Radboud University Medical Center

Who can join

Adults 16 to 25, any sex, with Internalizing Problems. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Promoting Resilience in Youth through Mindfulness mEditation (PRYME): Study protocol for a randomized controlled trial investigating the effects of mindfulness training as add-on to care-as-usual on internalizing problems, mental illness development, and associated brain and cogn
   Schepers M, Lagerweij P, Geurts D, Krause F, et al · · 2025 · PMID 39948492 · DOI 10.1186/s12888-024-06430-7