Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-21
SponsorMassachusetts General Hospital
About this trial
This study will test the hypotheses that adolescent with repetitive negative thinking who at at-risk for serious mental illness will show greater default mode network (DMN) connectivity than healthy controls, at-risk adolescents will show greater changes in DMN connectivity than healthy controls, and that a longer session of mindfulness based neurofeedback will lead to greater reduction in DMN connectivity. To do so, 50 adolescents with elevated repetitive negative thinking and 50 matched healthy control participants will be enrolled into a double-blind randomized clinical trial of a session of mindfulness training with either active mindfulness-basde neurofeedback or sham mindfulness-based neurofeedback.
Eligibility criteria
Qualifiers
Ages 13-21, inclusive
If <18 years old: Competent and willing to provide written informed assent AND have a parent/legal guardian who is competent and willing to provide written informed consent
If age ≥18 years: Competent and willing to provide written informed consent
Tanner puberty stage ≥3 (to minimize neuroendocrine variability)
Disqualifiers
Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, bipolar disorder, recurrent moderate or severe major depressive disorder, conduct disorder, developmental disorder (e.g., autism), post-traumatic stress disorder, or obsessive compulsive disorder
Severe lifetime substance use disorder
Unstable medical or neurologic condition as determined by study staff, history of epilepsy or seizure disorder, head injury, loss of consciousness >5 minutes by participant self-report
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).
Trial design
Treatments tested in this trial
- Mindfulness Training
- Mindfulness-based Neurofeedback (Real mbNF)
- Sham mindfulness-based neurofeedback (Sham mbNF)
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov