Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum

NCT03649815 | Completed Early Phase 1 Results

• 1 other identifier: 84-2016
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol describes an attempt to capture the development phase of a mobile support for individuals with schizophrenia. The intent is to describe and account for a rigorous development process that will result in the creation of a beta version that would be tested in a randomized trial for effectiveness - to be addressed in a subsequent protocol

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

schizophrenia; psychosis; mHealth; digital health

Outcome Measures

Primary Outcomes (3)

• Symptomatology

  The Brief Symptom Inventory (BSI) assesses the level of psychiatric symptomatology providing both total and subscale scores. All 53 items are 5-point likert with higher scores meaning higher symptomatology. For the overall score the total is used and can range from 0-212. Total scores from each of the 9 subscales are similarly used with higher scores meaning greater subscale symptomatology. Lowest scores for all are 0, with 20 the highest score for hostility, phobic anxiety, paranoid ideation, psychoticism; 16 the highest score for interpersonal sensitivity; 24 the highest for obsessive compulsive, depression, anxiety; and 28 for somatization.

  1 Month

• Recovery Process Engagement

  Personal Recovery Outcome Measure (PROM) was used to assess degree of engagement in the recovery process. The prom has 30 items, all 5 point likert with higher scores meaning more recovery engagement. The metric is the total score (0-120)/4 to provide an adjusted score. There are no subscales.

  1 month

• Treatment Adherence

  Brief Adherence Rating Scale (BARS) was used to examine implications of A4i for medication use. A total score ranging from 0-100 is provided with 100 indicating better adherence.

  1 month

Study Arms (1)

Use of mHealth Technology

EXPERIMENTAL

This single arm of the study involves the provision of the mobile health technology entitled App4Independence.

Combination Product: App4Independence

Interventions

App4Independence COMBINATION_PRODUCT

The mobile, app-based platform was designed to: * Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement * Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises) * Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness * Provide basic health/safety functionality and track level of wellness * Provide an anonymous peer-peer online network for strategy sharing * Provide an ambient sound detector to assist with identifying hallucinations

Use of mHealth Technology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 18 years of age or older
• Have a schizophrenia spectrum diagnosis
• Own and regularly use a smart phone equipped with an Android operating system and a talk and data plan
• Read and speak conversational English

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

No control condition limits comments on effectiveness and ability to control for confounders. The time period might speak to a lack of signal in medication adherence. Cannot speak to how well A4i would perform outside of the research context.

Results Point of Contact

• Title: Dr. Sean Kidd
• Organization: Centre for Addiction and Mental Health

sean.kidd@camh.ca

416-535-8501

Study Officials

• Sean Kidd, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 28, 2018
• Study Start: April 18, 2017
• Primary Completion: May 8, 2018
• Study Completion: May 8, 2018
• Last Updated: June 4, 2020
• Results First Posted: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available upon publication indefinitely.
• Access Criteria: Publically accessible.

Locations

CA (1)