Evaluation of mHealth for Serious Mental Illness

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of mHealth for Serious Mental Illness

Conditions
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Schizophrenia, Schizoaffective Disorder, Major Depressive Disorder, Bipolar Disorder

Intervention / Treatment
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* Other: Smartphone App
* Other: Waitlist Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission) Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression English speaker Exclusion Criteria: Does not live in the U.S. Has already participated in the study Unavailable for 60 days Currently incarcerated or hospitalized

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Instructed to download the app and use the app daily for 30 days. | Other: Smartphone App<br>* The application consists of content areas focused on mental health.<br>|
| Active Comparator: Waitlist Control<br>Waitlist control. | Other: Waitlist Control<br>* Waitlist control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Schizoaffective Disorder, Mobile Application, SMI, EHealth, E-Health, Health Technology, mHealth, m-Health, Mobile Health, Serious Mental Illness, Electronic Health