Trial Outcomes & Findings for Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum (NCT NCT03649815)
NCT ID: NCT03649815
Last Updated: 2020-06-04
Results Overview
The Brief Symptom Inventory (BSI) assesses the level of psychiatric symptomatology providing both total and subscale scores. All 53 items are 5-point likert with higher scores meaning higher symptomatology. For the overall score the total is used and can range from 0-212. Total scores from each of the 9 subscales are similarly used with higher scores meaning greater subscale symptomatology. Lowest scores for all are 0, with 20 the highest score for hostility, phobic anxiety, paranoid ideation, psychoticism; 16 the highest score for interpersonal sensitivity; 24 the highest for obsessive compulsive, depression, anxiety; and 28 for somatization.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
38 participants
Primary outcome timeframe
1 Month
Results posted on
2020-06-04
Participant Flow
Participant milestones
| Measure |
Use of mHealth Technology
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
App4Independence: The mobile, app-based platform was designed to:
* Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
* Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
* Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
* Provide basic health/safety functionality and track level of wellness
* Provide an anonymous peer-peer online network for strategy sharing
* Provide an ambient sound detector to assist with identifying hallucinations
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum
Baseline characteristics by cohort
| Measure |
Use of mHealth Technology
n=38 Participants
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
App4Independence: The mobile, app-based platform was designed to:
* Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
* Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
* Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
* Provide basic health/safety functionality and track level of wellness
* Provide an anonymous peer-peer online network for strategy sharing
* Provide an ambient sound detector to assist with identifying hallucinations
|
|---|---|
|
Age, Continuous
|
31.42 years
STANDARD_DEVIATION 8.60 • n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
27 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Canadian or African or African Caribbean
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Level of Education
Junior High/Middle School
|
4 Participants
n=5 Participants
|
|
Level of Education
High School
|
6 Participants
n=5 Participants
|
|
Level of Education
Tertiary Education
|
28 Participants
n=5 Participants
|
|
Employment
Full Time
|
2 Participants
n=5 Participants
|
|
Employment
Part Time
|
6 Participants
n=5 Participants
|
|
Employment
Casual
|
4 Participants
n=5 Participants
|
|
Employment
Student
|
11 Participants
n=5 Participants
|
|
Employment
Unemployed
|
9 Participants
n=5 Participants
|
|
Employment
Not In Labour Force
|
6 Participants
n=5 Participants
|
|
Diagnosis
Schizophrenia
|
24 Participants
n=5 Participants
|
|
Diagnosis
Schizoaffective
|
9 Participants
n=5 Participants
|
|
Diagnosis
Psychosis NOS or Psychosis comorbid with BPD
|
1 Participants
n=5 Participants
|
|
Diagnosis
ASD with prominent psychosis symptomatology
|
1 Participants
n=5 Participants
|
|
Age of first illness onsent/Age at 1st Hospitalization
|
24.16 years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
|
Mobile technology use
Hourly Use
|
30 Participants
n=5 Participants
|
|
Mobile technology use
Daily Use
|
8 Participants
n=5 Participants
|
|
Mobile technology use
Texting (1-5 times/day)
|
20 Participants
n=5 Participants
|
|
Mobile technology use
Emailing (1-5 times/day)
|
21 Participants
n=5 Participants
|
|
Mobile technology use
Social Media (1-5 times/day)
|
16 Participants
n=5 Participants
|
|
Brief Symptom Inventory
Total
|
46.21 units on a scale
STANDARD_DEVIATION 32.86 • n=5 Participants
|
|
Brief Symptom Inventory
Psychoticism
|
5.34 units on a scale
STANDARD_DEVIATION 4.63 • n=5 Participants
|
|
Brief Symptom Inventory
Somatization
|
4.95 units on a scale
STANDARD_DEVIATION 4.40 • n=5 Participants
|
|
Brief Symptom Inventory
Depression
|
6.47 units on a scale
STANDARD_DEVIATION 5.59 • n=5 Participants
|
|
Brief Symptom Inventory
Hostility
|
2.42 units on a scale
STANDARD_DEVIATION 2.41 • n=5 Participants
|
|
Brief Symptom Inventory
Phobic Anxiety
|
3.90 units on a scale
STANDARD_DEVIATION 4.11 • n=5 Participants
|
|
Brief Symptom Inventory
OCD
|
8.21 units on a scale
STANDARD_DEVIATION 5.06 • n=5 Participants
|
|
Brief Symptom Inventory
Anxiety
|
4.92 units on a scale
STANDARD_DEVIATION 5.50 • n=5 Participants
|
|
Brief Symptom Inventory
Paranoid Ideation
|
4.97 units on a scale
STANDARD_DEVIATION 4.54 • n=5 Participants
|
|
Brief Symptom Inventory
Interpersonal Sensitivity
|
4.45 units on a scale
STANDARD_DEVIATION 3.90 • n=5 Participants
|
|
Personal Recovery Outcome Measure
|
7.13 units on a scale
STANDARD_DEVIATION 1.66 • n=5 Participants
|
|
Brief Adherence Rating Scale
|
98.27 units on a scale
STANDARD_DEVIATION 3.10 • n=5 Participants
|
|
Living Circumstances
Alone in private dwelling
|
13 Participants
n=5 Participants
|
|
Living Circumstances
Private dwelling with parents
|
9 Participants
n=5 Participants
|
|
Living Circumstances
With roomates
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 MonthThe Brief Symptom Inventory (BSI) assesses the level of psychiatric symptomatology providing both total and subscale scores. All 53 items are 5-point likert with higher scores meaning higher symptomatology. For the overall score the total is used and can range from 0-212. Total scores from each of the 9 subscales are similarly used with higher scores meaning greater subscale symptomatology. Lowest scores for all are 0, with 20 the highest score for hostility, phobic anxiety, paranoid ideation, psychoticism; 16 the highest score for interpersonal sensitivity; 24 the highest for obsessive compulsive, depression, anxiety; and 28 for somatization.
Outcome measures
| Measure |
Use of mHealth Technology
n=38 Participants
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
App4Independence: The mobile, app-based platform was designed to:
* Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
* Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
* Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
* Provide basic health/safety functionality and track level of wellness
* Provide an anonymous peer-peer online network for strategy sharing
* Provide an ambient sound detector to assist with identifying hallucinations
|
|---|---|
|
Symptomatology
Psychoticism
|
4.34 score on a scale
Standard Deviation 4.23
|
|
Symptomatology
Somatization
|
4.29 score on a scale
Standard Deviation 5.40
|
|
Symptomatology
Depression
|
4.29 score on a scale
Standard Deviation 4.57
|
|
Symptomatology
Hostility
|
1.97 score on a scale
Standard Deviation 2.58
|
|
Symptomatology
Phobic Anxiety
|
2.97 score on a scale
Standard Deviation 3.75
|
|
Symptomatology
OCD
|
6.37 score on a scale
Standard Deviation 4.70
|
|
Symptomatology
Anxiety
|
4.63 score on a scale
Standard Deviation 4.81
|
|
Symptomatology
Paranoid Ideation
|
3.71 score on a scale
Standard Deviation 3.49
|
|
Symptomatology
Interpersonal Sensitivity
|
3.74 score on a scale
Standard Deviation 3.94
|
|
Symptomatology
Total
|
41.66 score on a scale
Standard Deviation 33.80
|
PRIMARY outcome
Timeframe: 1 monthPersonal Recovery Outcome Measure (PROM) was used to assess degree of engagement in the recovery process. The prom has 30 items, all 5 point likert with higher scores meaning more recovery engagement. The metric is the total score (0-120)/4 to provide an adjusted score. There are no subscales.
Outcome measures
| Measure |
Use of mHealth Technology
n=38 Participants
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
App4Independence: The mobile, app-based platform was designed to:
* Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
* Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
* Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
* Provide basic health/safety functionality and track level of wellness
* Provide an anonymous peer-peer online network for strategy sharing
* Provide an ambient sound detector to assist with identifying hallucinations
|
|---|---|
|
Recovery Process Engagement
|
7.45 score on a scale
Standard Deviation 1.63
|
PRIMARY outcome
Timeframe: 1 monthBrief Adherence Rating Scale (BARS) was used to examine implications of A4i for medication use. A total score ranging from 0-100 is provided with 100 indicating better adherence.
Outcome measures
| Measure |
Use of mHealth Technology
n=38 Participants
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
App4Independence: The mobile, app-based platform was designed to:
* Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
* Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
* Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
* Provide basic health/safety functionality and track level of wellness
* Provide an anonymous peer-peer online network for strategy sharing
* Provide an ambient sound detector to assist with identifying hallucinations
|
|---|---|
|
Treatment Adherence
|
98.94 score on a scale
Standard Deviation 2.35
|
Adverse Events
Use of mHealth Technology
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place