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A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Dartmouth Health logo

Dartmouth Health

Status

Completed

Conditions

Schizophrenia
Schizoaffective Disorder

Treatments

Behavioral: Treatment as usual
Behavioral: Device: Smartphone

Study type

Interventional

Funder types

Other

Identifiers

NCT01952041
MH103148-01 D14022

Details and patient eligibility

About

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.

Enrollment

149 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

149 participants in 2 patient groups

Device: Smartphone
Experimental group
Description:
Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services.
Treatment:
Behavioral: Device: Smartphone
Treatment as Usual
Active Comparator group
Description:
Treatment as usual included outpatient case management, linkage to services and medication monitoring.
Treatment:
Behavioral: Treatment as usual

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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