Status:
NOT_YET_RECRUITING
Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Repetitive Negative Thinking
Serious Mental Illness Symptoms
Eligibility:
All Genders
14-21 years
Phase:
NA
Brief 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 ...
Detailed Description
Approximately 90 at-risk adolescents ages 14-21 years old will be enrolled in a double-blind, randomized clinical trial. All participants will undergo a baseline clinical assessment (Visit 1), which w...
Eligibility Criteria
Inclusion
- 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
- 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 condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
- Pregnancy; a negative pregnancy test is required at enrollment
- Individuals who are under the legal protection of the government or state (Wards of the State)
- Inability to speak, read, or write English fluently
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06901232
Start Date
June 1 2025
End Date
September 1 2027
Last Update
March 28 2025
Active Locations (1)
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1
Massachusetts General Hospital, Center for Addiction Medicine, 101 Merrimac Street, Suite 320, Boston, MA 02114
Boston, Massachusetts, United States, 02114