Health TrialsbyHealthPanel

Effect of Mindfulness-based Neurofeedback for Adolescents With Elevated Repetitive Negative Thinking

ConditionsRepetitive Negative ThinkingNeurofeedback
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Mindfulness Training

    Behavioral

    A single 45-minute mindfulness training will be provided to all at-risk participants at visit 2. Clinically trained study staff will conduct the training with the aim of teaching "mental noting," a core mindfulness technique to be practiced and employed during neurofeedback. Mental noting is a major component of Vipassana (insight mindfulness meditation); its key principles include: "concentration", "observing sensory experience,'' "not 'efforting'", and "contentment".Specifically, participants will be taught to mentally label/note whatever sensation is most prominent in their sensory experience from moment to moment (e.g., seeing, hearing, feeling, thinking). Training will be personalized to identify scenarios in which mental noting can be applied in the context of each person's daily life, explaining the goal of using these strategies to manage distress in daily life.

  • Mindfulness-based Neurofeedback (Real mbNF)

    Behavioral

    Before the MRI scan, participants will practice mental noting by verbalizing their mental label, with the study clinician providing feedback. Participants will then complete a silent practice of mental noting while viewing simulated neurofeedback. All participants will be trained until they feel competent to use mental noting in the scanner. Study clinicians will show 85% fidelity on the mindfulness training assessment before working with participants and sessions will be recorded and 10% of sessions will be assessed quarterly for fidelity. During active mbNF (6 runs, 2.5 mins each), participants will use mental noting with the aim of controlling the visual feedback; specifically, they will attempt to move the position of the white dot toward the (upper) red circle and away from the (lower) blue circle.

  • Sham mindfulness-based neurofeedback (Sham mbNF)

    Behavioral

    During sham mbNF condition, participants will undergo similar MRI scan procedures. The primary difference in scan procedures is that rather than receiving mbNF, participants will view a visual display (i.e., white dot, red and blue circles) extracted from a previously acquired mbNF session. Thus, the visual display will be independent from brain activity in the sham condition and will simply mirror the stimuli observed by those in the mbNF group. This ensures that participants across groups are viewing equivalent stimuli for the same amount of overall time.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Healthy Control (HC)No intervention 0 interventions
Group B: Mindfulness-based neurofeedback (mbNF)Experimental treatment 2 interventions
Group C: Sham mindfulness-based neurofeedback (Sham mbNF)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Resting State Default Mode Network (DMN) Functional Connectivity

We will test whether at-risk adolescents have higher default mode network (DMN) functional connectivity (i.e., hyperconnectivity) compared to healthy control participants. A matched-sample t-test will examine baseline functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).

Time frame
Baseline
2

Change in Within-Person Default Mode Network (DMN) Functional Connectivity

A repeated measures ANCOVA will test interaction between within-participant change (2-level factor: pre- vs. post-mbNF) and between participant contrast (2-level: real- vs. sham-mbNF) in functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex) as the dependent measure.

Time frame
Pre-mbNF, Post-mbNF (30 minutes after pre-mbNF)
3

Time Effect on Within-DMN Connectivity

A repeated-measures ANCOVA will be used to test potential effect of time (three within-participant levels: pre-mbNF, first post-mbNF (15 minutes), second post-mbNF (30 minutes)) on functional connectivity between two canonical DMN nodes (personalized medial prefrontal cortex and posterior cingulate cortex).

Time frame
Pre-mbNF, First post-mbNF (15 minutes after pre-mbNF), Second post-mbNF (30 minutes after pre-mbNF)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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