Evaluation of mHealth for Serious Mental Illness

Not Applicable

Completed

• Conditions: Schizoaffective Disorder; Major Depressive Disorder; Schizophrenia; Bipolar Disorder
• Interventions: Other: Smartphone App; Other: Waitlist Control

• Registration Number: NCT04068467
• Lead Sponsor: University of Washington

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-22
• Study First Posted: 2019-08-28
• Study Start: 2020-01-06
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

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Exclusion Criteria

• Does not live in the U.S.
• Has already participated in the study
• Unavailable for 60 days
• Currently incarcerated or hospitalized

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Smartphone App	Instructed to download the app and use the app daily for 30 days.
Waitlist Control	Waitlist Control	Waitlist control.

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States