A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Schizophrenia Clinical Trial

Official title:

A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952041
• Other study ID #: MH103148-01 D14022
• Status: Completed
• Phase: N/A
• Start date: March 13, 2015
• Est. completion date: August 7, 2017

Study information

• Verified date: March 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: August 7, 2017
• Est. primary completion date: August 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis

• 18 years or older

• An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry

• Willing and able to provide informed consent

Exclusion Criteria:

• Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening)

• 6th grade reading level (determined by Wide Range Achievement Test- 4th Edition)

Related Conditions & MeSH terms

• Psychotic Disorders
• Recurrence
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Device: Smartphone

• Treatment as usual

Locations

Country	Name	City	State
United States	Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapses in Participants	A count of participants who experienced relapse, as defined as one of the following events: psychiatric hospitalization, a significant increase in the level of psychiatric care (i.e. frequency and intensity of services), an increase in medication in addition to a 25% increase in Brief Psychiatric Rating Scale (BPRS) from last assessment, suicidal or homicidal ideation that was clinically significant in the investigator's judgement, deliberate self-injury, violent behavior resulting in damage to another person or property.	1 year
Primary	Time to Relapse	Time to first relapse was defined as the time from randomization until the first relapse. Participants who did not experience a relapse were censored at their last known time relapse-free. Time-to-first relapse was estimated using the Kaplan-Meier method.	From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study).
Secondary	Psychotic Symptom Severity	Psychotic symptom severity assessed using the Brief Psychiatric Rating Scale (BPRS). This is an 18-item scale that rates severity of positive symptoms (including auditory hallucinations and persecutory ideation), and mood and behavioral symptoms. Items are rated by a clinical assessor on a scale of 1 (absent) to 7 (very severe). Total scores range from 18-126. Higher scores indicate worse symptoms.	Assessed at baseline and every three months for one year.
Secondary	Depression	Depression measured using the Calgary Depression Scales (CDSS). This is a 9-item assessment with values of 0 (absent) to 3 (severe) of depressive symptoms separate from positive, negative and extrapyramidal symptoms in people with schizophrenia. Total scores range from 0-27. A higher score indicates more severe symptoms.	Assessed at baseline and every three months for one year.
Secondary	Social Functioning	Social Functioning was assessed using the Social Functioning Scale (SFS). This is a 76-item questionnaire that assesses various aspects of social functioning and generates a number of subscale scores including social withdrawal, interpersonal behavior, pro-social activities, and an overall score of social functioning. The item values range from 0 (almost never) to 3 (often). Total scores range from 0-228. A higher score indicates greater social functioning.	Assessed at baseline and every three months for one year.