The aim of this study is to determine if mindfulness-based early intervention reduces internalizing symptoms in help-seeking youth and prevents their development into (serious) psychiatric illnesses. In addition we will examine putative changes in…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total internalizing problems as measured using the Adult Self Report (ASR) is
the primary outcome variable.
Secondary outcome
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).
Background summary
The majority of mental illnesses (75%) emerge before the age of 25 and many
have a life-long impact on (mental) health and psychosocial functioning. Early
intervention is crucial to improve outcomes and prevent long-term chronicity.
The early stage of (serious) mental illness is typically characterized by mild,
non-specific complaints such as anxiety, worrying, low mood, and social
withdrawal. These *internalizing problems* are increasingly common in youth and
associated with various adverse outcomes. Early intervention in help-seeking
youth may slow or prevent these early complaints from progressing into a
psychiatric disorder.
Mindfulness-based interventions (MBIs) have been proven effective in a range of
mental illnesses including internalizing disorders (i.e., anxiety and
depression). MBIs employ a variety of techniques designed to focus and maintain
attention on present-moment experience in a non-judgmental way. The deliberate
focusing of attention on thoughts, emotions, and bodily sensations in the
present moment, while not clinging to their content or valence, allows people
to experience their internal experiences in a new way: as transient mental
phenomena rather than reflections of absolute reality. This process of
decentering - a stepping back from mental experience - may increase awareness
of automatic patterns including fixed or schematized narratives about the self
and the world. This process may counteract negativity biases in
self-referential processing.
Self-related information is processed by brain regions in the cortical midline
comprising the Default Mode Network (DMN). Hyperactivity of the DMN during
self-referential processing and rumination has been shown in various
psychiatric disorders. Research has shown that mindfulness meditation reduces
the activity of the DMN during self-referential processing. Mindfulness
training may thus normalize the underlying deficits in self-referential
processing and thereby reduce risk for mental illness development
Study objective
The aim of this study is to determine if mindfulness-based early intervention
reduces internalizing symptoms in help-seeking youth and prevents their
development into (serious) psychiatric illnesses. In addition we will examine
putative changes in self-referential processing and associated brain regions.
Study design
The Promoting Resilience in Youth through Mindfulness mEditation (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
will be randomized to one of the two groups. Data is collected at baseline,
after the mindfulness training, at 2 months follow-up and at 6 months
follow-up. Multiple measurements will be conducted using questionnaires,
experimental tasks, and MRI scans. The aim is to include approximately 150
youth in this study.
Intervention
We will offer a mindfulness training program designed specifically for youth
with internalizing problems. The Learning to Offset Stress (LOS) (in Dutch:
Leren Omgaan met Stress) training program consists of a standard protocol based
on mindfulness based cognitive therapy (MBCT) combined with mindful physical
activity and yoga exercises. The 8-week training consists of weekly 2-hour
sessions and daily home practice. The 8th session will signify the end of the
training. After this last session participants are encouraged to continue home
self-practice. After 8 weeks a 2 hour booster session is provided to reinforce
mindfulness skills and to trouble-shoot with participants who experience
problems with their practice. The control group will receive treatment as
usual, mostly consisting of supportive counseling. When the study ends they
will be offered to participate in the mindfulness training.
Study burden and risks
The risks and discomfort associated with participating in this study are
estimated as low. Mindfulness training is acceptable and well-tolerated by
youth and adults and shows no harmful effects. The burden mainly constitutes
repeated assessments, including a diagnostic interview, questionnaires and
experimental tasks. In addition, two MRI scans will be performed. MRI is a safe
and non-invasive technique. Participants may experience some discomfort as a
result of lying down in a confined and noisy space. Therefore, we provide ear
protection and participants are screened for claustrophobia.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Youth between 16 and 25 years of age
2. Provide written informed consent
3. Adequate mastery of Dutch language
Exclusion criteria
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. Contraindications for MRI scanning (e.g., ferrous objects in or around the
body including braces, metal fragments, pace-maker, claustrophobia, body weight
> 250kg)
6. Moderate to severe substance use disorders (i.e., we will allow for mild
substance use)
7. Current active suicidality, current psychotic symptoms above clinical
cut-off for psychosis, or current trauma-related complaints above clinical
cut-off for PTSD.
8. Diagnosed or suspected (mild) intellectual disability (estimated IQ < 75)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82568.091.22 |