SchizophreniaNCT04602741
Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
A study testing A4i Intervention in people with Schizophrenia and Schizo Affective Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The effective treatment of schizophrenia is very challenging due to a number of factors. These include issues such as poor engagement with treatment plans and care providers, limited contacts with providers due to under-resourced health services, and the challenges inherent to schizophrenia symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Psychotic Disorders
- What is being tested?
- A4i Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be adults, 18 years of age or older, with a chart diagnosis of a DSM-5 schizophrenia spectrum illness confirmed by a structured diagnostic interview (SCID-5)40.
- All participants will be engaged in outpatient psychiatric treatment.
- Proficiency in English.
- Own and use an Android or iOS smartphone.
Who cannot join
- Lack of capacity with no identified substitute decision maker.
- Intellectual disability.
Trial locations and contacts
1 site in 1 country.
About this study
The effective treatment of schizophrenia is very challenging due to a number of factors.
These include issues such as poor engagement with treatment plans and care providers, limited contacts with providers due to under-resourced health services, and the challenges inherent to schizophrenia symptoms. The outcomes of these problems include frequent, lengthy, and costly hospital readmissions, low quality of life, high levels of distress, and difficulties engaging in valued community roles. Digital Health technologies are a promising model to help address these problems. They are a low cost and accessible form of support and have not been substantively developed or studied for people with schizophrenia spectrum illnesses. In this study, the feasibility of one such technology that is in development will be tested: App4Independence (A4i). A4i provides customized coping prompts, peer-peer networking, and a portal that facilitates better provider engagement. This research will provide critical information in the development of this new technology to address a key problem in the field - how to enhance care in a resource-limited context where provider-patient contacts are brief, infrequent, and rely on in the moment recall and self-advocacy by patients. These findings will lay the groundwork for a larger program of research and software development that will (i) validate the technology across multiple sites and, (ii) catalyze engagement with healthcare systems and caregiver networks to scale-out access to this promising resource.
Read the detailed description
Problem Statement: Among schizophrenia-spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems. Across healthcare domains, digital health is a rapidly growing area due to its potential reach, accessibility, low cost, and implications for the use of data to customize treatments and identify risk trajectories. Despite this promise and for reasons that are not entirely clear, the development and study of digital health strategies for more severe mental health conditions such as schizophrenia is much less developed than other domains of healthcare.
Objective: This feasibility trial will examine a digital health platform designed to enhance illness self-management and treatment engagement for individuals with schizophrenia.
Technology: The investigators and collaborators have developed and piloted a digital technology called App4Independence (A4i). This platform was designed to (i) help prevent social isolation through behavioral activation prompts and peer-peer strategy sharing, (ii) enhance coping with schizophrenia symptoms through functions that draw on evidence-based strategies (e.g., texted tips derived from cognitive and behavioral therapies) and provide a novel technology that assists with the identification of auditory hallucinations, (iii) enhance treatment adherence through scheduling, text and reminder functions, (iv) track level of wellness/risk and progress on personal goals through both active (self-ratings) and passive (sleep monitoring proxy) metrics, and (v) facilitate communications with care providers through a provider dashboard summarizing platform-collected data gathered between appointments.
Partners: This study builds on a partnership between the Centre for Addiction and Mental Health (research capability, mental health service and associated expertise, access to patient populations) and MEMOTEXT, a health technology company with a track record of success in digital health approaches across multiple health conditions and care contexts.
Study Design: This single blind, randomized controlled trial examines the feasibility of A4i. Feasibility metrics include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, study participants will be randomized to either treatment or control conditions, with pre-post outcomes measured over a 6-month period.
Implications: This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field - how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts. These findings will lay the groundwork for larger trials assessing the impacts of A4i on hospital readmission and functioning - providing essential evidence for commercialization and expanded access to this tool. This work is at the forefront of international efforts to explore and validate digital health approaches for schizophrenia.
- Being tested
- A4i Intervention
- Keywords
- Digital Health, Mobile Health, Smartphone
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A4i InterventionBehavioural
Also called A4i
6 months of the provision of A4i on the individual's own device.
| Study group | Role | What they receive |
|---|---|---|
| A4i Intervention | Experimental | App4Independence (A4i)
Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data.
Specific A4i functionality includes:
* Addressing social isolation and cognitive challenges through personalized prompts, scheduling of activities, and connections to a range of resources.
* Fostering illness self-management through evidence-informed content.
* A peer-peer engagement platform that facilitates strategy/tip sharing between users (anonymous and moderated).
* Daily wellness and goal attainment check-ins.
* An ambient sound detector with an oscilloscope-type indicator that assists individuals with auditory hallucinations separate hallucinations from real sounds.
* Passively collected data on phone use as a proxy for sleep.
* A provider dashboard. Both control and experimental condition participants will be receiving standard outpatient care (TAU). Receives: Behavioral: A4i Intervention |
| Treatment As Usual | No intervention | Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Number of individuals successfully recruited into the trial with a target of 91.
Measured: Through recruitment process an average of 1 week during a 21 month recruitment period.
Retention
Number of participants retained in the study through to post-intervention evaluation. The target is retaining 85% of participants recruited.
Measured: 6 months per participant in a 27 month period.
App Interactions
Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant.
Measured: Up to 6 months.
Incidence of Treatment-Emergent Adverse Events
Safety/tolerability will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and App use.
Measured: Up to 6 months.
App Likes
Total number of posts liked for each participant will be collected.
Measured: Up to 6 months.
Secondary outcomes (11)
BSI: Psychiatric Symptoms
General symptomatology will be assessed using the 53-item, 5-point likert scale Brief Symptom Inventory. Range 0-212. Lower values are better.
Measured: Baseline-6 months.
BARS: Medication Adherence
Medication adherence will be measured using the 4-item Brief Adherence Rating Scale with responses obtained by both providers and participants to assess medication adherence. There are two indicators, both are pre-post changes, "days not taken" and "days taken less", and both are not scored as a percentage.
The change scores for taking medication less (days taken less) and medication not taken (days not taken) were calculated as the difference from their 6 month score minus their baseline score. An value of "better" was assigned when the change score is > 0, value of "no change" was assigned when the change score is = 0, and a value of "worse" value was assigned when the change score is < 0.
Measured: Baseline-6 months.
STAR-P: Patient Relationship With Clinician
Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48.
Measured: Baseline-6 months.
QLS: Heinrichs-Carpenter Quality of Life Scale
The Heinrichs-Carpenter Quality of Life Scale, has 21 items, is well validated for schizophrenia, and captures sense of purpose, motivation, emotional and social interaction, role functioning, and engagement in regular activities. Higher values are better. Range 0-126.
Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre).
Measured: Baseline-6 months.
PANSS: Schizophrenia Symptoms
Schizophrenia-specific symptomatology will be assessed with the Positive and Negative Syndrome Scale. Lower values are better. Range 30-210.
Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre).
Measured: Baseline-6 months.
GAIN-SS
Global Appraisal of Individual Needs- Short Screener (GAIN-SS) - Instrument used for screening possible internalizing or externalizing psychiatric disorders, substance use disorders, or crime and violence problems. Lower values are better. Range 0-20.
Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre).
Measured: Baseline-6 months.
MOS: Treatment Adherence - General
The 5-item, 6-point likert scale Medical Outcomes Study general adherence scale to capture broader adherence to treatment recommendations (again triangulated with provider responses). Higher values are better. Range 5-26.
Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre).
Measured: Baseline-6 months.
Appointment Attendance
The average rate of scheduled appointments attended through EMR audit at CAMH or provider report at non-CAMH sites. No show vs. attending rates for both arms do not add up to 100% since an additional measure of cancelled rates was measured in the RCT. However, this variable was excluded from analysis since in the client's medical records it is unclear whether the clinician or client cancelled the appointment.
Measured: Baseline-6 months.
STAR-C: Clinician Relationship With Patient
Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship - Patient to measure patient perspective of provider-patient relationship. This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness. This measure supports patient and provider versions. Higher values are better. Range 0-48.
Pre-post change scores were calculated by subtracting the pre-score from the post score (= post - pre).
Measured: Baseline - 6 months
SUH - Patients
Service Use History measure to assess past month service use history. Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months.
Measured: baseline - 6 months
SUH - Clinicians
Service Use History measure to assess past month service use history of patient participant.
Number of visits due to physical health issues (in the past 6 months) included the sum of: family doctor, ER, walk-in clinic, and other services for the patient participant Number of visits due to mental health issues (in the past 6 months) included the sum of: sum of family doctor, outpatient, psychologist, social worker, community service for the patient participant There is no limit on the scale range since it is based on the number of visits to various services in the past 6 months.
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start4 Jan 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602741
- Sponsor's protocol ID
- 028/2020
- Status last verified
- Apr 2026
- First submitted
- 1 Oct 2020
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to share study metrics with participant identifiers removed (e.g., age, gender, ethnicity".
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
- ClinicalTrials.gov ID
- NCT04602741
- Acronym / sponsor ID
- 028/2020
- Keywords
- Digital Health, Mobile Health, Smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effective treatment of schizophrenia is very challenging due to a number of factors.
These include issues such as poor engagement with treatment plans and care providers, limited contacts with providers due to under-resourced health services, and the challenges inherent to schizophrenia symptoms. The outcomes of these problems include frequent, lengthy, and costly hospital readmissions, low quality of life, high levels of distress, and difficulties engaging in valued community roles. Digital Health technologies are a promising model to help address these problems. They are a low cost and accessible form of support and have not been substantively developed or studied for people with schizophrenia spectrum illnesses. In this study, the feasibility of one such technology that is in development will be tested: App4Independence (A4i). A4i provides customized coping prompts, peer-peer networking, and a portal that facilitates better provider engagement. This research will provide critical information in the development of this new technology to address a key problem in the field - how to enhance care in a resource-limited context where provider-patient contacts are brief, infrequent, and rely on in the moment recall and self-advocacy by patients. These findings will lay the groundwork for a larger program of research and software development that will (i) validate the technology across multiple sites and, (ii) catalyze engagement with healthcare systems and caregiver networks to scale-out access to this promising resource.
Detailed description
Problem Statement: Among schizophrenia-spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems. Across healthcare domains, digital health is a rapidly growing area due to its potential reach, accessibility, low cost, and implications for the use of data to customize treatments and identify risk trajectories. Despite this promise and for reasons that are not entirely clear, the development and study of digital health strategies for more severe mental health conditions such as schizophrenia is much less developed than other domains of healthcare.
Objective: This feasibility trial will examine a digital health platform designed to enhance illness self-management and treatment engagement for individuals with schizophrenia.
Technology: The investigators and collaborators have developed and piloted a digital technology called App4Independence (A4i). This platform was designed to (i) help prevent social isolation through behavioral activation prompts and peer-peer strategy sharing, (ii) enhance coping with schizophrenia symptoms through functions that draw on evidence-based strategies (e.g., texted tips derived from cognitive and behavioral therapies) and provide a novel technology that assists with the identification of auditory hallucinations, (iii) enhance treatment adherence through scheduling, text and reminder functions, (iv) track level of wellness/risk and progress on personal goals through both active (self-ratings) and passive (sleep monitoring proxy) metrics, and (v) facilitate communications with care providers through a provider dashboard summarizing platform-collected data gathered between appointments.
Partners: This study builds on a partnership between the Centre for Addiction and Mental Health (research capability, mental health service and associated expertise, access to patient populations) and MEMOTEXT, a health technology company with a track record of success in digital health approaches across multiple health conditions and care contexts.
Study Design: This single blind, randomized controlled trial examines the feasibility of A4i. Feasibility metrics include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, study participants will be randomized to either treatment or control conditions, with pre-post outcomes measured over a 6-month period.
Implications: This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field - how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts. These findings will lay the groundwork for larger trials assessing the impacts of A4i on hospital readmission and functioning - providing essential evidence for commercialization and expanded access to this tool. This work is at the forefront of international efforts to explore and validate digital health approaches for schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A4i Intervention | Experimental | Behavioral: A4i InterventionApp4Independence (A4i) Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data. Specific A4i functionality includes: * Addressing social isolation and cognitive challenges through personalized prompts, scheduling of activities, and connections to a range of resources. * Fostering illness self-management through evidence-informed content. * A peer-peer engagement platform that facilitates strategy/tip sharing between users (anonymous and moderated). * Daily wellness and goal attainment check-ins. * An ambient sound detector with an oscilloscope-type indicator that assists individuals with auditory hallucinations separate hallucinations from real sounds. * Passively collected data on phone use as a proxy for sleep. * A provider dashboard. Both control and experimental condition participants will be receiving standard outpatient care (TAU). |
| Treatment As Usual | No intervention | –Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be adults, 18 years of age or older, with a chart diagnosis of a DSM-5 schizophrenia spectrum illness confirmed by a structured diagnostic interview (SCID-5)40.
- All participants will be engaged in outpatient psychiatric treatment.
- Proficiency in English.
- Own and use an Android or iOS smartphone.
Key exclusion criteria (2 listed)
- Lack of capacity with no identified substitute decision maker.
- Intellectual disability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A4i InterventionAlso: A4i6 months of the provision of A4i on the individual's own device. | Behavioural | A4i Intervention |
Primary outcome
Recruitment
Time frame: Through recruitment process an average of 1 week during a 21 month recruitment period.
Number of individuals successfully recruited into the trial with a target of 91.
Retention
Time frame: 6 months per participant in a 27 month period.
Number of participants retained in the study through to post-intervention evaluation. The target is retaining 85% of participants recruited.
App Interactions
Time frame: Up to 6 months.
Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant.
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 6 months.
Safety/tolerability will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and App use.
App Likes
Time frame: Up to 6 months.
Total number of posts liked for each participant will be collected.
11 secondary outcomes
BSI: Psychiatric Symptoms
Time frame: Baseline-6 months.
BARS: Medication Adherence
Time frame: Baseline-6 months.
STAR-P: Patient Relationship With Clinician
Time frame: Baseline-6 months.
QLS: Heinrichs-Carpenter Quality of Life Scale
Time frame: Baseline-6 months.
PANSS: Schizophrenia Symptoms
Time frame: Baseline-6 months.
GAIN-SS
Time frame: Baseline-6 months.
MOS: Treatment Adherence - General
Time frame: Baseline-6 months.
Appointment Attendance
Time frame: Baseline-6 months.
STAR-C: Clinician Relationship With Patient
Time frame: Baseline - 6 months
SUH - Patients
Time frame: baseline - 6 months
SUH - Clinicians
Time frame: Baseline - 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The plan is to share study metrics with participant identifiers removed (e.g., age, gender, ethnicity".
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A4i Intervention in people with Schizophrenia and Schizo Affective Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Through recruitment process an average of 1 week during a 21 month recruitment period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.