Intervention of Attenuated Psychosis Syndrome With M-Health Technology

NCT03545685 | Completed

• 1 other identifier: 005680
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Adolescent - Emotional Problem

Outcome Measures

Primary Outcomes (1)

• Memory and attention scores

  Memory and attention score will be assessed at 3 month followup

  3rd month

Study Arms (2)

SMART

EXPERIMENTAL

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

Other: specific memory and attention realtime training

Control group

OTHER

Participants in this group will serve as control group

Other: specific memory and attention realtime training

Interventions

specific memory and attention realtime training OTHER

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.

Control group; SMART

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Florida A&M University: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: June 4, 2018
• Study Start: August 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

CN (1)