Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents (NCT06901232) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents
United States90 participantsStarted 2027-09
Plain-language summary
The study will test the hypothesis that mindfulness-based neurofeedback (mbNF) will improve repetitive negative thinking and social and role functioning over sham neurofeedback in adolescents at risk for serious mental illness. To do so, 90 adolescents ages 14-21 with elevated repetitive negative thinking will be enrolled into a double-blind randomized clinical trial of sessions of mindfulness training with either active mindfulness-based neurofeedback or sham neurofeedback and three months of mindfulness practice and follow up.
Who can participate
Age range14 Years – 21 Years
SexALL
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Inclusion Criteria:
* Ages 14-21, inclusive
* Recurrent negative thinking, defined as PTQ-C (\<18 years) or PTQ (18 years or older) total score \>30 and at least two questions scored 3 or 4.
* Able to understand study procedures, read, and write in English
* If age is 18 years or older: Competent and willing to provide written informed consent
* If age is less than 18 years: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
* Access to a mobile device to complete daily survey assessments
Exclusion Criteria:
* Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, anxiety disorder, bipolar disorder, oppositional defiant disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or eating disorder
* Substance use disorder, moderate or severe in past six months.
* Unstable medical or neurologic condition, epilepsy or seizure disorder, head injury, loss of consciousness \>5 minutes
* MRI contraindications (i.e. presence of ferromagnetic implants, cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, magnetic dental implants claustrophobia).
* Visual, auditory, or cognitive impairment (IQ\<80 based on the Wechsler Abbreviated Intelligence Scale (WASI)) that may make it difficult to participate.
* Any cond…