Evaluation of mHealth for Serious Mental Illness

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT04068467

Collaborator

(none)

315

Enrollment

Location

Arms

15.8

Actual Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Major Depressive Disorder Bipolar Disorder	Other: Smartphone App Other: Waitlist Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

315 participants

Allocation:

Randomized

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 :

Jan 6, 2020

Actual Primary Completion Date :

May 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active 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 Waitlist control.	Other: Waitlist Control Waitlist control

Arm

Intervention/Treatment

Experimental: Active

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

Waitlist control.

Other: Waitlist Control

Waitlist control

Outcome Measures

Primary Outcome Measures

Change in Depressive Symptoms [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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