Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia, Schizoaffective Disorder, Self Management of Schizophrenia, SOS, Serious Mental Illness, Psychosis, Social Dysfunction, Medication Adherence, Mobile Application, EHealth, E-Health, Health Technology, mobile health, m-Health, electronic health
Brief summary
This 2-arm clinical trial piloted a mobile Self-Management of Schizophrenia (SOS) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. Researchers compared an intervention arm using the SOS system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.
Interventions
BEHAVIORALMobile Application
BEHAVIORALTreatment as Usual (TAU)
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* DSM-IV (Diagnostic and Statistical Manual IV) criteria for schizophrenia or schizoaffective disorder based on a chart diagnosis; * 18 years or older; * Prescribed oral antipsychotic medication; and * A rating of 3 or lower on one of the three items which comprise the Domination by Symptoms factor from the Recovery Assessment Scale, indicating patient-rated need for illness self-management
Exclusion criteria
* Hearing, vision, or motor impairment that make it impossible to operate a smartphone or respond to prompts (determined using demonstration smartphone for screening); and * English reading level below 4th grade (determined using the Wide Range Achievement Test - 4th Edition)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Psychotic Symptoms | Baseline, week 12 | Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms. |
| Change in Social Functioning | Baseline, week 12 | Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal & Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in System Use | 4 weeks | System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system. |
| Usability and Satisfaction | 4 weeks | Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning. |
Countries
United States
Participant flow
Recruitment details
Individuals with schizophrenia or schizoaffective disorder who were receiving services were recruited through flyers in waiting rooms and bulletin boards at treatment centers, and through referrals from clinical staff. Enrollment was open from November 2015 to July 2016.
Pre-assignment details
N=3 enrolled participants were not assigned because N=1 did not pass a competency screener, N=1 did not meet Recovery Assessment Scale inclusion criteria, and N= 1 was no longer interested prior to completing baseline.
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
Treatment as Usual | 25 |
| Mobile Application Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.
Mobile Application | 26 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | extended hospitalization | 1 | 1 |
Baseline characteristics
| Characteristic | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Continuous | 43.0 years STANDARD_DEVIATION 12.5 | 42.5 years STANDARD_DEVIATION 13.4 | 42.7 years STANDARD_DEVIATION 12.8 |
| Beck Depression Inventory (BDI) | 17.68 units on a scale STANDARD_DEVIATION 10.85 | 14.12 units on a scale STANDARD_DEVIATION 8.07 | 15.90 units on a scale STANDARD_DEVIATION 9.46 |
| Beliefs about Medicines Questionnaire - General (BMQ - General) | 19.96 units on a scale STANDARD_DEVIATION 4.57 | 20.32 units on a scale STANDARD_DEVIATION 4.36 | 20.14 units on a scale STANDARD_DEVIATION 4.46 |
| Beliefs about Medicines Questionnaire - Specific (BMQ - Specific) | 32.56 units on a scale STANDARD_DEVIATION 5.24 | 32.20 units on a scale STANDARD_DEVIATION 4.49 | 32.38 units on a scale STANDARD_DEVIATION 4.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 24 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Insomnia Severity Index (ISI) | 7.56 units on a scale STANDARD_DEVIATION 7.17 | 6.73 units on a scale STANDARD_DEVIATION 5.68 | 7.15 units on a scale STANDARD_DEVIATION 6.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 24 Participants | 46 Participants |
| Schizophrenia Patient Activation Measure (SPAM) | 56.28 units on a scale STANDARD_DEVIATION 5.73 | 57.48 units on a scale STANDARD_DEVIATION 5.25 | 56.88 units on a scale STANDARD_DEVIATION 5.49 |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 16 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
| Working Alliance Inventory (WAI) | 64.68 units on a scale STANDARD_DEVIATION 12.93 | 66.28 units on a scale STANDARD_DEVIATION 11.43 | 65.48 units on a scale STANDARD_DEVIATION 12.18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 26 |
| other Total, other adverse events | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 0 / 25 | 0 / 26 |
Outcome results
Primary
Change in Severity of Psychotic Symptoms
Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.
Time frame: Baseline, week 12
Population: N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Change in Severity of Psychotic Symptoms | baseline | 20.20 units on a scale | Standard Error 3.2 |
| Treatment as Usual | Change in Severity of Psychotic Symptoms | 12 weeks | 21.98 units on a scale | Standard Error 3.24 |
| Mobile Application | Change in Severity of Psychotic Symptoms | baseline | 19.88 units on a scale | Standard Error 3.2 |
| Mobile Application | Change in Severity of Psychotic Symptoms | 12 weeks | 20.96 units on a scale | Standard Error 3.24 |
p-value: 0.8595% CI: [-8.37, 6.96]Linear mixed effects model
Primary
Change in Social Functioning
Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal & Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning.
Time frame: Baseline, week 12
Population: N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment as Usual | Change in Social Functioning | baseline | 27.60 units on a scale | Standard Error 1.15 |
| Treatment as Usual | Change in Social Functioning | 12 weeks | 29.28 units on a scale | Standard Error 1.17 |
| Mobile Application | Change in Social Functioning | baseline | 25.96 units on a scale | Standard Error 1.15 |
| Mobile Application | Change in Social Functioning | 12 weeks | 26.34 units on a scale | Standard Error 1.17 |
p-value: 0.4495% CI: [-4.66, 2.06]Linear mixed effects model
Secondary
Change in System Use
System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system.
Time frame: 4 weeks
Population: This data was collected in a previous field trial, not in this randomized controlled trial.
Secondary
Usability and Satisfaction
Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning.
Time frame: 4 weeks
Population: This data was collected in a previous field trial, not in this randomized controlled trial.