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Completed

NCT Number: NCT01952041

A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

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.

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Key information

Conditions

Schizophrenia Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Psychotic Disorders Recurrence Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Device: Smartphone

Behavioral

Treatment as Usual

Behavioral

Primary outcomes

  1. Relapses in Participants

    Time frame: 1 year

    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.

  2. Time to Relapse

    Time frame: 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).

    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.

Secondary outcomes

  1. Psychotic Symptom Severity

    Time frame: Assessed at baseline and every three months for one year.

    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.

  2. Depression

    Time frame: Assessed at baseline and every three months for one year.

    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.

  3. Social Functioning

    Time frame: Assessed at baseline and every three months for one year.

    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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 27, 2013
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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