Evaluation of mHealth for Serious Mental Illness

Schizophrenia Clinical Trial

Official title:

Evaluation of mHealth for Serious Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068467
• Other study ID #: STUDY00006898
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• Smartphone App
The application consists of content areas focused on mental health.
• Waitlist Control
Waitlist control

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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