Clinical trial NCT03545685: Intervention of Attenuated Psychosis Syndrome With M-Health Technology
Official title: Enhancing Intervention of Attenuated Psychosis Syndrome With M-Health Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent - Emotional Problem
Lead sponsor: Florida A&M University
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The investigators will develop a culturally sensitive smart phone application to enhance neurocognitive function (memory and attention in particular) of participants with attenuated psychosis syndrome (APS).

Detailed description: The investigator will conduct a pilot study of 80 APS subjects (age 18-45). Forty subjects will be randomly put in the SMART plus routine care (RC) group and 40 to RC group only. At baseline and 3-month follow-ups, all subjects will complete questionnaires including Mobile App Rating Scale SMART feasibility and engagement. 1:1 in-depth interviews will be conducted at the two time points to cross-validate the findings obtained from the questionnaires. The questionnaires and in-depth interviews for APS subjects for the RC group seek to explore their preference and likelihood to use SMART given the opportunity. Examine Cognitive Function Change. In order to prepare for future large scale randomized clinical trials, the investigator will examine the effectiveness of SMART in improving working memory and attention of APS subjects. At baseline and 3-month follow-ups, all subjects will complete MATRICS Consensus Cognitive Battery (MCCB) subtests measuring working memory (Spatial Span) and attention (Continuous Performance Test-Identical Pairs). A between and within group design allows examining change of outcome variables over time and group differences. Enhance mHealth research capacity of SMHC at individual and organization levels.

Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 45 years old.
* Understand and sign an informed consent (or assent for minors) document.
* Must meet the substance use criteria: No DSM IV Alcohol or Drug Dependence in the past 3 months; No use on the day of assessment, clearly not high or hung-over.
* Meet diagnostic criteria for a prodromal syndrome. If under the age of 19 and meets diagnostic criteria for Schizotypal Personality Disorder or meets the diagnostic criteria called the Criteria for Prodromal Syndromes (COPS) which are operationalized as follows:

  * Genetic Risk and Deterioration Syndrome (GRDS): First degree relative with psychosis or subject with Schizotypal Personality Disorder and a 30% drop in GAF score compared to one year ago, sustained over the past month, or
  * Attenuated Positive Symptoms Syndrome (APSS): Severity rating of moderate (rating of 3), moderately severe (4) or severe but not psychotic (5) on any one of the five SOPS positive symptoms; symptom occurs at above severity level at an average frequency of at least once per week in the past month; symptom must have begun in the past year or currently rates at least one scale point higher than rated 12 months previously, or
  * Brief Intermittent Psychotic Syndrome (BIPS): Severity rating of psychotic intensity (6) on any of the 5 SOPS positive symptoms 94; symptom is present at least several minutes per day at a frequency of at least once per month; symptom(s) must have reached a psychotic intensity in the past 3 months; symptom is not seriously disorganizing or dangerous; symptom(s) do not last for more than 1 hour/day at an average frequency of 4 days/week over 1 month.

Exclusion Criteria:

* Meet criteria for current or lifetime Axis I psychotic disorder, including affective psychoses and psychosis NOS.
* Impaired intellectual functioning (i.e. IQ\<70).
* Past or current history of a 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).
* The diagnostic prodromal symptoms are clearly caused by an Axis 1 disorder, including substance use disorders, in the judgment of the evaluating clinician. Other non-psychotic disorders will not be exclusionary (e.g. substance abuse disorder, major depression, anxiety disorders, Axis II Disorders), as long as the disorder does not account for the diagnosis of prodromal symptoms.

Primary outcomes:
measure: Memory and attention scores
timeFrame: 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Shangai
country: China
facility: Shanghai Mental Health Center
Study officials:
References: