Evaluation of mHealth for Serious Mental Illness
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|ClinicalTrials.gov Identifier: NCT04068467|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : February 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder||Other: Smartphone App Other: Waitlist Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of mHealth for Serious Mental Illness|
|Actual Study Start Date :||January 6, 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Instructed to download the app and use the app daily for 30 days.
Other: Smartphone App
The application consists of content areas focused on mental health.
Active Comparator: Waitlist Control
Other: Waitlist Control
- Change in Depressive Symptoms [ Time Frame: Baseline, 30 days, 60 days ]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.
- Change in Paranoid Thinking [ Time Frame: Baseline, 30 days, 60 days ]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.
- Change in Anxiety Symptoms [ Time Frame: Baseline, 30 days, 60 days ]The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety.
- Change in Psychotic Symptoms [ Time Frame: Baseline, 30 days, 60 days ]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.
- Participant Acceptability [ Time Frame: 30 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068467
|Contact: Suzanne M Meller, MPH, MSWemail@example.com|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Suzanne Meller, MPH, MSW 206-221-7364 firstname.lastname@example.org|
|Principal Investigator:||Dror Ben-Zeev, PhD||University of Washington|