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Promoting Resilience in Youth through Mindfulness mEditation

Promoting Resilience in Youth through Mindfulness mEditation - PRYME

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53899
Enrollment
200
Registered
2023-01-10
Start date
2023-07-07
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internalising problems psychological distress

Interventions

We will offer a mindfulness training program designed specifically for youth&nbsp
with internalizing problems. The Learning to Offset Stress (LOS) (in Dutch:&nbsp
Leren Omgaan met Stress) training program consists of a standard protocol based&nbsp
on mindfulness based cognitive therapy (MBCT) combined with mindful physical&nbsp
activity and yoga exercises. The 8-week training consists of weekly 2-hour&nbsp
sessions and daily home practice. The 8th session will signify the end of the&nbsp
training. After this last session participants are encouraged to continue home&nbsp
self-practice. After 8 weeks a 2 hour booster session is provided to reinforce&nbsp
mindfulness skills and to trouble-shoot with participants who experience&nbsp
problems with their practice. The control group will receive treatment as&nbsp
usual, mostly consisting of supportive counseling. When the study ends they&nbsp
will be offered to participate in the mindfulness training.The healthy control group will not receive an intervention

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: RCT participants (help-seeking youth)  1. Help-seeking youth between 16 and 25 years of age  2. Provide written informed consent  3. Adequate mastery of Dutch language Healthy control group participants:  1. Youth between 16 and 25 years of age  2. Provide written informed consent  3. Adequate mastery of Dutch language

Exclusion criteria

Exclusion criteria: RTC participants (help-seeking youth)  1. Lifetime diagnosis of severe major depression, bipolar disorder, schizophrenia spectrum disorder, personality disorder, and post-traumatic stress disorder  2. History of major medical illness or neurological illness  3. Participation in a mindfulness programme in the past year  4. Current participation in another intervention study  5. Moderate to severe substance use disorders (i.e., we will allow for mild substance use)  6. Current active suicidality, current psychotic symptoms above clinical cut-off for psychosis, or current trauma-related complaints above clinical cut-off for PTSD.  7. Diagnosed or suspected (mild) intellectual disability (estimated IQ < 75) Healthy control group participants:  1. Any lifetime mental illness  2. Having a first-degree family member with serious mental illness (i.e., major affective, psychotic or personality disorder)  3. Current clinical symptoms that fulfill any DSM-5 mental disorder criteria, as determined using the MINI-S-DSM-5 administered by a psychiatrist or resident in psychiatry  4. History of major medical illness or neurological illness  5. Participation in a mindfulness program in the past year  6. Diagnosed or suspected (mild) intellectual disability (estimated IQ<75)  7. Contraindications for MRI scanning

Design outcomes

Primary

MeasureTime frame
Total internalizing problems as measured using the Adult Self Report (ASR) is the primary outcome variable.

Secondary

MeasureTime frame
In a clinical interview, participants will be screened for DSM-5 diagnoses using the Mini International Neuropsychiatric Interview - Screen for DSM-5 (MINI-S-DSM-5). Mindfulness skills will be measured using The Five Facets of Mindfulness Questionnaire - short form (FFMQ - SF) and self-compassion will be measured using the Self-Compassion Scale (SCS). Overall mental well-being will be measured using the Mental Health Continuum - short form (MHC-SF). Rumination will be measured using the Rumination-Reflection Questionnaire (RRQ) - Brooding subscale. Stress levels will be measured using the Perceived Stress Scale - 10 item (PSS-10). Resilience will be measured using the Connors-Davidson Resilience Scale (CD-RISC). Self-esteem will be measured using the Rosenberg Self Esteem Scale (RSES). Adaptive self-concepts will be measured using the Adaptive Self-Concepts Questionnaire (ASCQ). Experiential avoidance will be measured using the Acceptance and Action Questionnaire (AAQ-II). Demographic data will be collected and the degree to which people adhere to the training curriculum (and continue mindfulness practice after completing the training) will be recorded using the Mindfulness Adherence Questionnaire (MAQ). In addition, a number of experimental tasks will be administered inside and outside of the MRI scanner. The Self-Referent Encoding Task (SRET), which measures biases in positive and negative self-related information processing, will be performed in the scanner. An escape and avoidance task designed to measure automatic avoidance behaviours will be performed outside the scanner. In addition, participants have the option to perform an online Pavlovian to Instrumental Transfer (PIT) task and controllability task (CBU).Finally, the main objectives of adding the HC group are to 1) recruit a sample of healthy youth (16-25 yo) to assess neurocognitive mechanisms associated with mental illness development in a normative sample, 2) determine how these mechanisms differ bet

Countries

Netherlands

Contacts

Public ContactG. Collin

Radboud Universitair Medisch Centrum

guusje.collin@radboudumc.nl0243098988

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)