Effect of Network-based Real Time Neurofeedback Augmentation of Mindfulness Practice on Recurrent Negative Thinking in Adolescents at Risk for Serious Mental Illness
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in repetitive negative thinking (RNT)
Study Overview
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 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.
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 will serve as an important baseline for daily symptom fluctuation and use of mindfulness strategies prior to training. Approximately 1-2 weeks after the baseline assessments, all participants will complete an in-person visit (Visit 2) in which they will complete a brief MRI scan (resting state localizer) and a 45-minute mindfulness training. After the mindfulness training, participants will be randomized in a 1:1 ratio to receive either active or sham neurofeedback (n=45 each group). Randomization will be stratified by information obtained at the baseline assessment: biological sex, prior daily/near daily mindfulness practice for 8 weeks or more. A study staff member with no participant contact will create randomization tables in REDCap to alloacte participants to either active or sham mbNF. Participants and staff will remain blinded to assignment. Participants will then complete another MRI session what will include resting state scans as well as the active or sham mbNF. Approximately 1-2 weeks later, participants will return for another in-person visit (Visit 3) that includes a mindfulness refresher and repeats the procedures of Visit 2. Participants will briefly rate their mindfulness practice daily for three months using a brief, online survey. At 1-, 3- and 12-months post-neurofeedback, participants will complete self-report and clinician-rated assessments to probe repetitive negative thinking and prodromal psychiatric symptoms.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 14 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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 Criteria
- •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
Arms & Interventions
Active mindfulness-based neurofeedback (Active mbNF)
Participants will:
- Receive a 45-minute mindfulness training
- Receive two sessions of active mindfulness-based neurofeedback
Intervention: Mindfulness Training (Behavioral)
Active mindfulness-based neurofeedback (Active mbNF)
Participants will:
- Receive a 45-minute mindfulness training
- Receive two sessions of active mindfulness-based neurofeedback
Intervention: Active mindfulness-based neurofeedback (Active mbNF) (Behavioral)
Sham mindfulness-based neurofeedback (Sham mbNF)
Participants will:
- Receive a 45-minute mindfulness training
- Receive two sessions of sham neurofeedback
Intervention: Mindfulness Training (Behavioral)
Sham mindfulness-based neurofeedback (Sham mbNF)
Participants will:
- Receive a 45-minute mindfulness training
- Receive two sessions of sham neurofeedback
Intervention: Sham mindfulness-based neurofeedback (Behavioral)
Outcomes
Primary Outcomes
Change in repetitive negative thinking (RNT)
Time Frame: 2 weeks
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.
Secondary Outcomes
- Change in psychotic symptom severity(2 weeks)
- Change in depressive symptom severity(2 weeks)
- Change in social and occupational functioning(2 weeks)
- Change in worry symptom severity(2 weeks)
- Change in rumination symptom severity(2 weeks)
Investigators
Anne Eden Evins
Founding Director Massachusetts General Hospital Center for Addiction Medicine; Cox Family Professor of Psychiatry, Harvard Medical School
Massachusetts General Hospital