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This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Instructed to download the app and use the app daily for 30 days. |
|
| Waitlist Control | Active Comparator | Waitlist control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone App | Other | The application consists of content areas focused on mental health. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Depressive Symptoms | The Beck Depression Inventory is a self-reported 21-item inventory, scores range from 0-63 and items are summed to compute the total score. A higher score represents more depressive symptoms. | Baseline, 30 days, 60 days |
| Change in Paranoid Thinking | The Green Paranoid Thoughts Scale Parts A & B is a 32-item scale, the total score is summed with a range of 16-80. A higher score represents more symptoms of paranoid thinking. | Baseline, 30 days, 60 days |
| Change in Anxiety Symptoms | The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety. | Baseline, 30 days, 60 days |
| Change in Psychotic Symptoms | The Hamilton Program for Schizophrenia Voices Questionnaire is a 13-item questionnaire, 9 of the items are scored 0 (least severe or impairing) to 4 (most severe). The total score is intended to indicate the overall severity of psychotic symptoms. Total score range is 0-36. The remaining 4 items are intended to assess qualitative aspects. | Baseline, 30 days, 60 days |
| Participant Acceptability | Participant Acceptability/Usability Ratings Scale is a 26-item scale measuring participant-rated acceptability of the intervention. Participants rate statements on a scale of Disagree (0), Neutral (1), or Agree (2). Items are summed to create a total score and a higher total score indicates greater acceptability. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dror Ben-Zeev, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34766913 | Derived | Ben-Zeev D, Chander A, Tauscher J, Buck B, Nepal S, Campbell A, Doron G. A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE. J Med Internet Res. 2021 Nov 12;23(11):e29201. doi: 10.2196/29201. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
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| Waitlist Control |
| Other |
Waitlist control |
|
| D000068105 | Bipolar and Related Disorders |