Mechanisms of Response to Therapeutic Intervention in Clinical High Risk (CHR) for Psychosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-35
SponsorBeth Israel Deaconess Medical Center

About this trial

This study, "Psychobiological Follow-up Study of Transition from Prodrome to Early Psychosis", will be conducted in collaboration with the Shanghai Mental Health Center (SMHC) and several data processing sites in the United States. The current study builds on findings from the investigator's previous work that identified several biomarkers in participants at clinical high risk (CHR) for psychosis that may be related to clinical outcomes such as the development of psychosis. This study responds to the critical need to understand links between biomarkers (could be clinical, cognitive, biological or other abnormalities) and later clinical outcomes.

Participants will receive either one of two real interventions or one of two sham (a procedure that looks like the real treatment but is not) interventions, involving either: 1. repetitive transcranial magnetic stimulation (rTMS)1; or 2. mindfulness-based real time fMRI neurofeedback (mb-rt-fMRI-NFB). Both procedures will measure brain capacity for change in CHR individuals, thus paving the way forward for future therapeutic interventions.

The main hypotheses to be addressed by this study are:

1. \- Following real interventions, novel biomarkers will be more effective predictors of clinical outcome than standard biomarkers in participants at CHR for psychosis 2. \- Following real interventions, novel biomarkers will be more effective predictors of clinical outcomes in participants who received the real intervention than in participants who received sham treatments 3. \- The novel interventions will reduce biomarker abnormalities in individuals with CHR relative to their own baselines and relative to healthy controls (HC) 4. \- The sham interventions will will not reduce biomarker abnormalities in individuals with CHR relative to their own baselines or relative to HC

Eligibility criteria

Qualifiers

Male or female between 15 and 35 years old.

Can understand and sign an informed consent (or assent for minors) document.

No Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) Alcohol or Drug Dependence in the past 3 months;

No use on the day of assessment, clearly not intoxicated or hung-over.

Disqualifiers

Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis Not Otherwise Specified (NOS) at the baseline assessment

Impaired intellectual functioning (i.e., Intelligence Quotient (IQ)<70) at baseline.

Past history of or current clinically significant central nervous system disorder that may contribute to prodromal symptoms or confound their assessment.

Traumatic Brain Injury that is rated as 7 or above on the Traumatic Brain Injury screening instrument (signifying a significant brain injury with persistent sequelae) or current concussion that interferes with any assessment measures.

Trial design

Treatments tested in this trial

  • Mb-rt-fMRI-NFB
  • Sham mb-rt-fMRI-NFB
  • rTMS
  • Sham rTMS

Treatment groups

300 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Beth Israel Deaconess Medical Center

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Collaborator

Florida A&M University

Collaborator

Brigham and Women's Hospital

Collaborator

Massachusetts General Hospital

Collaborator

VA Boston Healthcare System

Collaborator

National Institute of Mental Health (NIMH)

Collaborator