Evaluation of mHealth for Serious Mental Illness
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04068467|
Recruitment Status : Completed
First Posted : August 28, 2019
Last Update Posted : August 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Major Depressive Disorder Bipolar Disorder||Other: Smartphone App Other: Waitlist Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||315 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|
|Actual Primary Completion Date :||May 1, 2021|
|Actual Study Completion Date :||May 1, 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.
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): NCT04068467
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Dror Ben-Zeev, PhD||University of Washington|