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Evaluation of mHealth for Serious Mental Illness

Evaluation of mHealth for Serious Mental Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04068467
Enrollment
315
Registered
2019-08-28
Start date
2020-01-06
Completion date
2021-05-01
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder, Schizophrenia

Keywords

Schizophrenia, Schizoaffective Disorder, Mobile Application, SMI, EHealth, E-Health, Health Technology, mHealth, m-Health, Mobile Health, Serious Mental Illness, Electronic Health

Brief summary

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

Interventions

OTHERSmartphone App

The application consists of content areas focused on mental health.

OTHERWaitlist Control

Waitlist control

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Depressive SymptomsBaseline, 30 days, 60 daysThe 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 ThinkingBaseline, 30 days, 60 daysThe 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 SymptomsBaseline, 30 days, 60 daysThe 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 SymptomsBaseline, 30 days, 60 daysThe 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 Acceptability30 daysParticipant 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026