Promoting Resilience in Youth Through Mindfulness mEditation

NCT05916651 | Recruiting

• 3 other identifiers: NL82568.091.2260-63600-98-105429875
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

mindfulness; internalizing problems; self-referential processing; youth; help-seeking; resilience

Outcome Measures

Primary Outcomes (1)

• The total number of internalizing problems as measured with the ASR, computed as the sum of responses on the items comprising withdrawn, somatic complaints, anxiety and depression subscales.

  The ASR is a 126-item self-report questionnaire assessing aspects of adaptive functioning and problems. Items are rated on a 3-point scale: 0-Not True, 1-Somewhat or Sometimes True, 2-Very True or Often True.

  end-of-treatment (T1), approximately 3 months after the baseline assessment

Secondary Outcomes (15)

• Presence of psychiatric disorders as per DSM-5 criteria on the MINI - Simplified for DSM-5 (MINI-S-DSM-5). Of note: the MINI-S is a separate instrument from the Mini Neuropsychiatric Interview (MINI) for DSM-5 by Prof. Sheehan.

  6-months follow-up (T3), approximately 9 months after the baseline assessment

• The Ruminative-Reflection Questionnaire (RRQ) - brooding subscale score.

  end-of-treatment (T1), approximately 3 months after the baseline assessment

• The Perceived Stress Scale (PSS-10) total score.

  end-of-treatment (T1), approximately 3 months after the baseline assessment

• The Rosenberg Self-Esteem Scale (RSES) total score.

  end-of-treatment (T1), approximately 3 months after the baseline assessment

• The Adaptive Self-Concept Questionnaire (ASCQ) total score.

  end-of-treatment (T1), approximately 3 months after the baseline assessment

Study Arms (2)

Intervention (LOS training) + care as usual (intervention group)

EXPERIMENTAL

Intervention group: mindfulness (LOS) training + CAU

Behavioral: Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training; Behavioral: Care as usual

Care-as-usual (CAU)-only (control group)

ACTIVE COMPARATOR

Control group: CAU-only

Behavioral: Care as usual

Interventions

Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training BEHAVIORAL

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.

Intervention (LOS training) + care as usual (intervention group)

Care as usual BEHAVIORAL

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.

Care-as-usual (CAU)-only (control group); Intervention (LOS training) + care as usual (intervention group)

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth between 16 and 25 years of age
• Provide written informed consent
• Adequate mastery of Dutch language

You may not qualify if:

• 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
• Moderate to severe substance use disorders (i.e., we will allow for mild substance use)
• Current active suicidality, current psychotic symptoms above clinical cut-off for psychosis, or current trauma-related complaints above clinical cut-off for PTSD.
• Diagnosed or suspected (mild) intellectual disability (estimated IQ \< 75)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Donders Centre for Cognitive Neuroimaging: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Brain & Behavior Research Foundation: collaborator

Study Sites (2)

Radboud university medical center (Radboudumc)

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Donders Centre for Cognitive Neuroimaging (DCCN)

Nijmegen, Gelderland, 6525 EN, Netherlands

ACTIVE NOT RECRUITING

Related Publications (1)

• Schepers M, Lagerweij P, Geurts D, Krause F, Ouden HD, Cools R, Speckens A, Collin G. 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 cognitive processes in help-seeking youth. BMC Psychiatry. 2025 Feb 14;25(1):126. doi: 10.1186/s12888-024-06430-7.

  PMID: 39948492 DERIVED

Central Study Contacts

Guusje Collin, MD, PhD

CONTACT

+31 24 30 98988; guusje.collin@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The PRYME study is a Randomized Controlled Trial (RCT) that compares care-as-usual (e.g., supportive counseling by a student psychologist or mental health nurse-practitioner) with care -as-usual + mindfulness training. Participants are randomized to either of these conditions. Data is collected at baseline, after the mindfulness training (approximately 3 months after baseline), and at 2 and 6 months follow-up. Multiple measurements will be conducted using questionnaires, experimental tasks in and out of the MRI scanner, MRI scans, and clinical interviews.

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 23, 2023
• Study Start: July 7, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-07

Locations

NL (2)