NCT01952041

A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Completed NA Results posted Last updated 21 June 2019

What this trial tests

NA trial testing Device: Smartphone in Schizophrenia in 149 participants. Completed in 7 August 2017.

Timeline

13 March 2015

Primary endpoint
7 August 2017

7 August 2017

Quick facts

Lead sponsor	Dartmouth-Hitchcock Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	149
Start date	13 March 2015
Primary completion	7 August 2017
Estimated completion	7 August 2017
Sites	1 location across United States

Drugs / interventions tested

• Device: Smartphone
• Treatment as usual

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →

Sponsor

Dartmouth-Hitchcock Medical Center

Who can join

18 and older, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Relapses in Participants Primary · 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.

Group	Value	95% CI
Device: Smartphone	20
Treatment as Usual	22

Time to Relapse Primary · 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.

Group	Value	95% CI
Device: Smartphone	13.8	NA – NA
Treatment as Usual	NA	9.7 – NA

Psychotic Symptom Severity Secondary · 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.

baseline

Group	Value	95% CI
Device: Smartphone	26.3	± 7.2
Treatment as Usual	27.4	± 8.2

3 months

Group	Value	95% CI
Device: Smartphone	24.9	± 6.4
Treatment as Usual	25.3	± 5.3

6 months

Group	Value	95% CI
Device: Smartphone	25.3	± 6.5
Treatment as Usual	23.7	± 5.1

9 months

Group	Value	95% CI
Device: Smartphone	25.6	± 6.4
Treatment as Usual	24.0	± 5.6

12 months

Group	Value	95% CI
Device: Smartphone	25.0	± 7.7
Treatment as Usual	26.3	± 8.5

Depression Secondary · 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.

baseline

Group	Value	95% CI
Device: Smartphone	1.4	± 2.0
Treatment as Usual	2.1	± 2.7

3 months

Group	Value	95% CI
Device: Smartphone	1.7	± 2.2
Treatment as Usual	1.7	± 2.1

6 months

Group	Value	95% CI
Device: Smartphone	1.4	± 2.3
Treatment as Usual	1.7	± 2.3

9 months

Group	Value	95% CI
Device: Smartphone	2.1	± 2.6
Treatment as Usual	1.7	± 2.0

12 months

Group	Value	95% CI
Device: Smartphone	1.4	± 2.2
Treatment as Usual	2.5	± 2.5

Social Functioning Secondary · 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.

baseline

Group	Value	95% CI
Device: Smartphone	142.0	± 29.0
Treatment as Usual	135.1	± 30.2

3 months

Group	Value	95% CI
Device: Smartphone	144.9	± 30.3
Treatment as Usual	140.0	± 27.2

6 months

Group	Value	95% CI
Device: Smartphone	145.8	± 27.2
Treatment as Usual	140.1	± 28.1

9 months

Group	Value	95% CI
Device: Smartphone	134.5	± 30.5
Treatment as Usual	143.2	± 28.0

12 months

Group	Value	95% CI
Device: Smartphone	138.1	± 27.9
Treatment as Usual	141.1	± 26.1

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Predicting Early Warning Signs of Psychotic Relapse From Passive Sensing Data: An Approach Using Encoder-Decoder Neural Networks.
   Adler DA, Ben-Zeev D, Tseng VW, Kane JM, et al · · 2020 · cited 64× · PMID 32865506 · DOI 10.2196/19962
2. Relationships between smartphone social behavior and relapse in schizophrenia: A preliminary report.
   Buck B, Scherer E, Brian R, Wang R, et al · · 2019 · cited 62× · PMID 30940400 · DOI 10.1016/j.schres.2019.03.014
3. Machine learning for passive mental health symptom prediction: Generalization across different longitudinal mobile sensing studies.
   Adler DA, Wang F, Mohr DC, Choudhury T. · · 2022 · cited 25× · PMID 35476787 · DOI 10.1371/journal.pone.0266516
4. Assessing the relationship between routine and schizophrenia symptoms with passively sensed measures of behavioral stability.
   He-Yueya J, Buck B, Campbell A, Choudhury T, et al · · 2020 · cited 22× · PMID 33230099 · DOI 10.1038/s41537-020-00123-2
5. Predicting Psychotic Relapse in Schizophrenia With Mobile Sensor Data: Routine Cluster Analysis.
   Zhou J, Lamichhane B, Ben-Zeev D, Campbell A, et al · · 2022 · cited 19× · PMID 35404256 · DOI 10.2196/31006
6. mHealth-Assisted Detection of Precursors to Relapse in Schizophrenia.
   Buck B, Hallgren KA, Campbell AT, Choudhury T, et al · · 2021 · cited 11× · PMID 34135781 · DOI 10.3389/fpsyt.2021.642200
7. Forecasting mental states in schizophrenia using digital phenotyping data.
   Jean T, Guay Hottin R, Orban P. · · 2025 · cited 3× · PMID 39919138 · DOI 10.1371/journal.pdig.0000734