Back to resultsIntervention of Attenuated Psychosis Syndrome With M-Health Technology
Primary Purpose
Adolescent - Emotional Problem
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
specific memory and attention realtime training
Sponsored by
About this trial
This is an interventional other trial for Adolescent - Emotional Problem
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.
Sites / Locations
- Shanghai Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SMART
Control group
Arm Description
The subjects in SMART training group will receive add-on SMART intervention for 3 months. Subjects will play cognitive games for 1 hour per day, five days per week. SMART will track game time, resource use, and text messaging information on a daily basis, which allows researchers/clinicians to monitor subjects' daily SMART activities. Daily end-of-day RedPocket incentives will be delivered to subjects' designated account based on their resource use and game time. Top 5 APS subjects who play the game for the most time in a week will be rewarded
Participants in this group will serve as control group
Outcomes
Primary Outcome Measures
Memory and attention scores
Memory and attention score will be assessed at 3 month followup
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03545685
Brief Title
Intervention of Attenuated Psychosis Syndrome With M-Health Technology
Official Title
Enhancing Intervention of Attenuated Psychosis Syndrome With M-Health Technology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida A&M University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent - Emotional Problem
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMART
Arm Type
Experimental
Arm Description
The subjects in SMART training group will receive add-on SMART intervention for 3 months. Subjects will play cognitive games for 1 hour per day, five days per week. SMART will track game time, resource use, and text messaging information on a daily basis, which allows researchers/clinicians to monitor subjects' daily SMART activities. Daily end-of-day RedPocket incentives will be delivered to subjects' designated account based on their resource use and game time. Top 5 APS subjects who play the game for the most time in a week will be rewarded
Arm Title
Control group
Arm Type
Other
Arm Description
Participants in this group will serve as control group
Intervention Type
Other
Intervention Name(s)
specific memory and attention realtime training
Intervention Description
The investigator will conduct a pilot study of 80 APS subjects (age 18-45). The investigator will examine SMART feasibility and user engagement using a randomized control trial research design. Using a simple random method, 40 APS subjects will be randomly assigned to the experimental group to receive add-on SMART intervention for 3 months and 40 APS subjects will just get naturalistic treatment with no SMART intervention. At baseline and 3-month follow-up, subjects will complete questionnaires on app use habits and attitudes towards SMART feasibility and engagement. In-depth interviews will be conducted at both time points to cross-validate the findings obtained from the questionnaires.
Primary Outcome Measure Information:
Title
Memory and attention scores
Description
Memory and attention score will be assessed at 3 month followup
Time Frame
3rd month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shangai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intervention of Attenuated Psychosis Syndrome With M-Health Technology
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