Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum
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|ClinicalTrials.gov Identifier: NCT03649815|
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Spectrum and Other Psychotic Disorders||Combination Product: App4Independence||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testing the Feasibility and Outcomes of a Digital Health Support for Individuals With Schizophrenia Spectrum Mental Illnesses|
|Actual Study Start Date :||April 18, 2017|
|Actual Primary Completion Date :||May 8, 2018|
|Actual Study Completion Date :||May 8, 2018|
Experimental: Use of mHealth Technology
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
Combination Product: App4Independence
The mobile, app-based platform was designed to:
- Symptomatology [ Time Frame: 1 Month ]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.
- Recovery Process Engagement [ Time Frame: 1 month ]Personal 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.
- Treatment Adherence [ Time Frame: 1 month ]Brief 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649815
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M5T 1R8|
|Principal Investigator:||Sean Kidd, PhD||Centre for Addiction and Mental Health|