Promoting Resilience in Youth Through Mindfulness mEditation
ConditionInternalizing Problems
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Learning to Offset Stress (LOS) (in Dutch: Leren Omgaan met Stress) training
BehavioralThe 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.
Care as usual
BehavioralYouth 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.
Treatment groups
155 Participants
are divided into 2 treatment groupsGroup A: Intervention (LOS training) + care as usual (intervention group)Experimental treatment 2 interventions
Group B: Care-as-usual (CAU)-only (control group)Active comparator 1 intervention
Trial outcomes
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.
Time frame
end-of-treatment (T1), approximately 3 months after the baseline assessmentSecondary outcomes
1
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.
The MINI-S-DSM-5 is a structured diagnostic interview for psychiatric disorders, which assesses 16 common psychiatric disorders.
Time frame
6-months follow-up (T3), approximately 9 months after the baseline assessment2
The Ruminative-Reflection Questionnaire (RRQ) - brooding subscale score.
The RRQ is used to measure two factors of self-focused attention: rumination and reflection). The brooding subscale consists of 12 items that are measured on a 5-point Likert scale.
Time frame
end-of-treatment (T1), approximately 3 months after the baseline assessment3
The Perceived Stress Scale (PSS-10) total score.
The Perceived Stress Scale (PSS-10) is a self-report questionnaire measuring (perceived) stress. It consists of 10 items that are measured using a 4-point Likert scale. Total score ranges from 0-40.
Time frame
end-of-treatment (T1), approximately 3 months after the baseline assessment4
The Rosenberg Self-Esteem Scale (RSES) total score.
The RSES is a self-report questionnaire that assesses global self-esteem. It consists of 10 items that are measured using a 4-point Likert scale.
Time frame
end-of-treatment (T1), approximately 3 months after the baseline assessmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov