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New treatment option for Repetitive Negative Thinking
Official title Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking
ClinicalTrials.gov ID: NCT07055217
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 21. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- If age ≥18 years: Competent and willing to provide written informed consent
- Tanner puberty stage ≥3 (to minimize neuroendocrine variability)
- Able to understand study procedures, read, and write in English
You likely can't join if
- Any of the following lifetime mental health disorders by DSM-V criteria: psychotic disorders, bipolar disorder, recurrent moderate or severe major...
- 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...
- MRI contraindications (i.e. presence of ferromagnetic implants, cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips...
- Visual, auditory, or cognitive impairment (IQ\<80 based on the Wechsler Abbreviated Intelligence Scale (WASI)) that may make it difficult to...
- Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
See the full eligibility criteria
- 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)
- Able to understand study procedures, read, and write in English
- Access to a mobile device to complete daily surveys Additional for At-Risk Adolescents - Recurrent negative thinking, defined as PTQ/PTQ-C total score \>30 with at least two items rated as 3 (Often) or 4 (Almost Always)...
- 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...
- 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...
- 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 the time of enrollment for any individuals of childbearing potential
- Individuals who are under the legal protection of the government or state (Wards of the State)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 13 years to 21 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.