Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Mobile Application, Relapse, SMI, EHealth, E-Health, Health Technology, mHealth, m-Health, Mobile Health, Serious Mental Illness, Electronic Health
Brief 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.
Interventions
BEHAVIORALDevice: Smartphone
BEHAVIORALTreatment as usual
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded clinical assessors also conducted assessments with all participants at baseline and every 3 months post-randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapses in Participants | 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. |
| Time to Relapse | 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
| Measure | Time frame | Description |
|---|---|---|
| Psychotic Symptom Severity | 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. |
| Depression | 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. |
| Social Functioning | 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. |
Countries
United States
Participant flow
Recruitment details
Eligible individuals at a medical clinic were identified through electronic medical records and approached by a staff member to be recruited for the study. Recruitment was open from March 2015 until July 2016.
Pre-assignment details
N=23 participants withdrew before randomization: N=1 did not complete baseline, N=15 no longer receiving services at the study site, N=1 incarcerated, N=6 no longer interested in participating.
Participants by arm
| Arm | Count |
|---|---|
| Device: Smartphone 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. | 62 |
| Treatment as Usual Treatment as usual included outpatient case management, linkage to services and medication monitoring. | 64 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 9 | 16 |
| Overall Study | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Treatment as Usual | Total | Device: Smartphone |
|---|---|---|---|
| Age, Continuous | 36 years STANDARD_DEVIATION 13 | 37 years STANDARD_DEVIATION 13 | 37 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 32 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 94 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 9 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 34 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 28 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) White | 21 Participants | 44 Participants | 23 Participants |
| Sex: Female, Male Female | 28 Participants | 54 Participants | 26 Participants |
| Sex: Female, Male Male | 36 Participants | 72 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 62 | 0 / 64 |
| other Total, other adverse events | 0 / 62 | 0 / 64 |
| serious Total, serious adverse events | 0 / 62 | 0 / 64 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device: Smartphone | Relapses in Participants | 20 Participants |
| Treatment as Usual | Relapses in Participants | 22 Participants |
p-value: 0.8Chi-squared
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.
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).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Device: Smartphone | Time to Relapse | 13.8 months |
| Treatment as Usual | Time to Relapse | NA months |
p-value: 0.4395% CI: [0.42, 1.44]Regression, Cox
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.
Time frame: Assessed at baseline and every three months for one year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device: Smartphone | Depression | 3 months | 1.7 score on a scale | Standard Deviation 2.2 |
| Device: Smartphone | Depression | 9 months | 2.1 score on a scale | Standard Deviation 2.6 |
| Device: Smartphone | Depression | 6 months | 1.4 score on a scale | Standard Deviation 2.3 |
| Device: Smartphone | Depression | 12 months | 1.4 score on a scale | Standard Deviation 2.2 |
| Device: Smartphone | Depression | baseline | 1.4 score on a scale | Standard Deviation 2 |
| Treatment as Usual | Depression | 12 months | 2.5 score on a scale | Standard Deviation 2.5 |
| Treatment as Usual | Depression | baseline | 2.1 score on a scale | Standard Deviation 2.7 |
| Treatment as Usual | Depression | 3 months | 1.7 score on a scale | Standard Deviation 2.1 |
| Treatment as Usual | Depression | 6 months | 1.7 score on a scale | Standard Deviation 2.3 |
| Treatment as Usual | Depression | 9 months | 1.7 score on a scale | Standard Deviation 2 |
p-value: 0.8495% CI: [-0.22, 0.26]Mixed Models Analysis
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.
Time frame: Assessed at baseline and every three months for one year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device: Smartphone | Psychotic Symptom Severity | 3 months | 24.9 score on a scale | Standard Deviation 6.4 |
| Device: Smartphone | Psychotic Symptom Severity | baseline | 26.3 score on a scale | Standard Deviation 7.2 |
| Device: Smartphone | Psychotic Symptom Severity | 6 months | 25.3 score on a scale | Standard Deviation 6.5 |
| Device: Smartphone | Psychotic Symptom Severity | 12 months | 25.0 score on a scale | Standard Deviation 7.7 |
| Device: Smartphone | Psychotic Symptom Severity | 9 months | 25.6 score on a scale | Standard Deviation 6.4 |
| Treatment as Usual | Psychotic Symptom Severity | 12 months | 26.3 score on a scale | Standard Deviation 8.5 |
| Treatment as Usual | Psychotic Symptom Severity | 9 months | 24.0 score on a scale | Standard Deviation 5.6 |
| Treatment as Usual | Psychotic Symptom Severity | baseline | 27.4 score on a scale | Standard Deviation 8.2 |
| Treatment as Usual | Psychotic Symptom Severity | 3 months | 25.3 score on a scale | Standard Deviation 5.3 |
| Treatment as Usual | Psychotic Symptom Severity | 6 months | 23.7 score on a scale | Standard Deviation 5.1 |
p-value: 0.5895% CI: [-0.58, 1.02]Mixed Models Analysis
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.
Time frame: Assessed at baseline and every three months for one year.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device: Smartphone | Social Functioning | 3 months | 144.9 score on a scale | Standard Deviation 30.3 |
| Device: Smartphone | Social Functioning | 9 months | 134.5 score on a scale | Standard Deviation 30.5 |
| Device: Smartphone | Social Functioning | 6 months | 145.8 score on a scale | Standard Deviation 27.2 |
| Device: Smartphone | Social Functioning | 12 months | 138.1 score on a scale | Standard Deviation 27.9 |
| Device: Smartphone | Social Functioning | baseline | 142.0 score on a scale | Standard Deviation 29 |
| Treatment as Usual | Social Functioning | 12 months | 141.1 score on a scale | Standard Deviation 26.1 |
| Treatment as Usual | Social Functioning | baseline | 135.1 score on a scale | Standard Deviation 30.2 |
| Treatment as Usual | Social Functioning | 3 months | 140.0 score on a scale | Standard Deviation 27.2 |
| Treatment as Usual | Social Functioning | 6 months | 140.1 score on a scale | Standard Deviation 28.1 |
| Treatment as Usual | Social Functioning | 9 months | 143.2 score on a scale | Standard Deviation 28 |
p-value: 0.0695% CI: [-5.4, 0.04]Mixed Models Analysis