Health TrialsbyHealthPanel

Mindfulness-based Neurofeedback to Reduce Negative Thinking in CHARMS Adolescents

ConditionsRepetitive Negative ThinkingSerious Mental Illness Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-21
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness Training

    Behavioral

    All participants will complete a single 45-minute mindfulness training at Visit 2, with a refresher prior to the second mbNF session at Visit 3. 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.

  • Active mindfulness-based neurofeedback (Active 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. Participants will be trained until they feel competent to use mental noting in the scanner. During active mbNF (6 runs, 2.5 minutes each), participants will use mental noting with the aim of controlling 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

    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. Participants will be trained until they feel competent to use mental noting in the scanner. During sham mbNF, participants will view a visual display (white dot, red and blue circles) extracted from a previously acquired mbNF session. The 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 participants across groups are viewing equivalent stimuli for the same amount of overall time.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Active mindfulness-based neurofeedback (Active mbNF)Experimental treatment 2 interventions
Group B: Sham mindfulness-based neurofeedback (Sham mbNF)Sham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in repetitive negative thinking (RNT)

Perseverative Thinking Questionnaire- Child Version (PTQ-C), is a content-independent measure of RNT, with 15 items, rated on a 5- point scale (never, almost never, sometimes, often, almost always), with excellent internal consistency, Cronbach's alpha=0.95, in both clinical and non-clinical samples, validated and normed in clinical and non-clinical adolescent and young adult samples as a transdiagnostic research tool that has been shown to predict MDD. Higher scores indicate greater RNT.

Time frame
2 weeks

Secondary outcomes

1

Change in psychotic symptom severity

Psychotic symptoms will be assessed using the Brief Psychiatric Rating Scale (BPRS), a well validated, 18-item, interview-based measure of positive and negative psychotic, depressive, and general psychiatric symptoms that is sensitive to treatment effects and is included in the PhenXToolkit. Scores for each item range from 1 (not present) and 7 (extremely severe). Higher scores indicate greater severity of psychotic symptoms.

Time frame
2 weeks
2

Change in depressive symptom severity

Depressive symptoms will be assessed by the Quick Inventory of Depressive Symptoms - (QIDS-C) for participants ages 18 and older and the Quick Inventory of Depressive Symptoms - Adolescent Version (QIDS-A17) for participants under 18 years old. The QIDS is a 17-item clinician rated scale that assesses mood, sleep, appetite, and suicidal ideation. Higher scores indicate greater depressive symptom severity.

Time frame
2 weeks
3

Change in social and occupational functioning

Social and occupational functioning will be assessed using the Social and Occupational Functioning Assessment Scale (SOFAS). It focuses exclusively on the individual's level of social and occupational functioning and is not directly influenced by the overall severity of the individual's psychological symptoms. Scores range from 0 to 100, with lower scores indicating greater levels of impairment.

Time frame
2 weeks
4

Change in worry symptom severity

The Penn State Worry Questionnaire will be used to assess RNT in the form of worry. The scale has a possible range from 0 to 42. Severity cutoffs are as follows: normal (0-15), at risk (top 3-7%; 16-18), clinically elevated (top 2%; 19+). Participants under 18 years old will be assessed using the Penn State Worry Questionnaire for Children.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

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

Massachusetts General Hospital

Lead sponsor

Source ClinicalTrials.gov

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