Psychotic DisordersNCT04379349
Using Short Message Service as a Means of Clinical Engagement in Early Psychosis
A study testing SMS text messaging - interactive check-in in people with Psychotic Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Engagement with clinical services for youth with early psychosis represents a significant challenge, with up to 40% of patients dropping out of treatment in the first year. This has been linked to worse illness outcomes and represents a significant barrier to recovery for these patients. Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- SMS text messaging - interactive check-in
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- between the ages of 16-29
- a diagnosis of an affective or non-affective psychotic disorder (i.e., Bipolar or Major Depressive Disorders with Psychotic Features, Schizophrenia Spectrum Disorders, Other Specified Psychotic Disorders, Substance Induced Psychosis and Attenuated Psychotic Syndrome)
- eligible for follow-up within the Slaight Family Centre for Youth in Transition early intervention service
- within the first 6 months of treatment
Who cannot join
- involved in another intervention study
- do not have a personal cell phone number
Trial locations and contacts
1 site in 1 country.
About this study
Engagement with clinical services for youth with early psychosis represents a significant challenge, with up to 40% of patients dropping out of treatment in the first year. This has been linked to worse illness outcomes and represents a significant barrier to recovery for these patients. This study aims to evaluate the efficacy of short message service (SMS) as a means of improving clinical engagement in early-episode psychosis populations by bridging contact between appointments with weekly check-ins/reminders. These weekly check-ins during the first year of treatment will serve as an additional opportunity to reach out to patients and give them a chance to do the same with their care teams, with patient responses triggering clinician follow-up if necessary.
- Conditions
- Psychotic Disorders
- Being tested
- SMS text messaging - interactive check-in, SMS text messaging - inactive control
- Keywords
- SMS text messaging, Clinical engagement
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS text messaging - interactive check-inBehavioural
Interactive SMS text message check-ins delivered once weekly to participants.
SMS text messaging - inactive controlBehavioural
Minimally interactive SMS text message delivered once weekly to participants.
| Study group | Role | What they receive |
|---|---|---|
| Active SMS | Experimental | Weekly interactive SMS text messaging check-ins. Receives: Behavioral: SMS text messaging - interactive check-in |
| Sham SMS | Sham comparator | Weekly minimally interactive SMS text messages. Receives: Behavioral: SMS text messaging - inactive control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service Engagement Scale (SES)
Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)
Measured: 9 months
Appointment Attendance
Percentage of attended clinic appointments
Measured: 9 months
Secondary outcomes (12)
Emergency Department Visits
Number of emergency department visits
Measured: 9 months
Hospitalizations
Number of hospitalizations
Measured: 9 months
Social Functioning Scale (SFS)
Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning)
Measured: 9 months
Personal and Social Performance Scale (PSP)
Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning)
Measured: 9 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)
Self-reported measure of subjective quality of life (minimum score = 1, maximum score = 5, higher score indicates better quality of life)
Measured: 9 months
Clinical Global Impression (CGI)
Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity)
Measured: 9 months
Brief Psychiatric Rating Scale (BPRS)
Interview-based measure of the severity of psychiatric symptoms (minimum score = 24, maximum score = 168, higher score indicates higher severity of symptoms)
Measured: 9 months
Scale for the Assessment of Negative Symptoms (SANS)
Interview-based measure of the severity of negative symptoms (minimum score = 0, maximum score = 110, higher score indicates higher severity of symptoms)
Measured: 9 months
Apathy Evaluation Scale (AES)
Interview-rated measure of the severity of motivation deficits (minimum score = 18, maximum score = 72, higher score indicates worse motivation deficits)
Measured: 9 months
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Rater-administered measure of cognitive functioning (scores indicate standardized Z-scores with no pre-defined minimum or maximum score, higher score indicates better cognitive functioning)
Measured: 9 months
Drug Attitude Inventory (DAI-10)
Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence)
Measured: 9 months
Scale To Assess Therapeutic Relationships - Patient Version (STAR-P)
Self-reported measure of the clinician-patient therapeutic relationship (minimum score = 0, maximum score = 48, higher score indicates better therapeutic relationship)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start1 Jan 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies 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
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Foussias, Centre for Addiction and Mental Health
- Investigators
- George Foussias, MD PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379349
- Sponsor's protocol ID
- 091-2017
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Arcey JN, Zhao H, Wang W, Voineskos AN, Kozloff N, Kidd SA, Foussias G. An SMS text messaging intervention to improve clinical engagement in early psychosis: A pilot randomized-controlled trial. Schizophr Res. 2024 Feb;264:416-423. doi: 10.1016/j.schres.2024.01.012. Epub 2024 Jan 18.
PubMed 38241785
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Short Message Service as a Means of Clinical Engagement in Early Psychosis
- ClinicalTrials.gov ID
- NCT04379349
- Acronym / sponsor ID
- 091-2017
- Conditions
- Psychotic Disorders
- Keywords
- SMS text messaging, Clinical engagement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Engagement with clinical services for youth with early psychosis represents a significant challenge, with up to 40% of patients dropping out of treatment in the first year. This has been linked to worse illness outcomes and represents a significant barrier to recovery for these patients. This study aims to evaluate the efficacy of short message service (SMS) as a means of improving clinical engagement in early-episode psychosis populations by bridging contact between appointments with weekly check-ins/reminders. These weekly check-ins during the first year of treatment will serve as an additional opportunity to reach out to patients and give them a chance to do the same with their care teams, with patient responses triggering clinician follow-up if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active SMS | Experimental | Behavioral: SMS text messaging - interactive check-inWeekly interactive SMS text messaging check-ins. |
| Sham SMS | Sham comparator | Behavioral: SMS text messaging - inactive controlWeekly minimally interactive SMS text messages. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- between the ages of 16-29
- a diagnosis of an affective or non-affective psychotic disorder (i.e., Bipolar or Major Depressive Disorders with Psychotic Features, Schizophrenia Spectrum Disorders, Other Specified Psychotic Disorders, Substance Induced Psychosis and Attenuated Psychotic Syndrome)
- eligible for follow-up within the Slaight Family Centre for Youth in Transition early intervention service
- within the first 6 months of treatment
Key exclusion criteria (2 listed)
- involved in another intervention study
- do not have a personal cell phone number
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 |
|---|---|---|
| SMS text messaging - interactive check-inInteractive SMS text message check-ins delivered once weekly to participants. | Behavioural | Active SMS |
| SMS text messaging - inactive controlMinimally interactive SMS text message delivered once weekly to participants. | Behavioural | Sham SMS |
Primary outcome
Service Engagement Scale (SES)
Time frame: 9 months
Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)
Appointment Attendance
Time frame: 9 months
Percentage of attended clinic appointments
12 secondary outcomes
Emergency Department Visits
Time frame: 9 months
Hospitalizations
Time frame: 9 months
Social Functioning Scale (SFS)
Time frame: 9 months
Personal and Social Performance Scale (PSP)
Time frame: 9 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)
Time frame: 9 months
Clinical Global Impression (CGI)
Time frame: 9 months
Brief Psychiatric Rating Scale (BPRS)
Time frame: 9 months
Scale for the Assessment of Negative Symptoms (SANS)
Time frame: 9 months
Apathy Evaluation Scale (AES)
Time frame: 9 months
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Time frame: 9 months
Drug Attitude Inventory (DAI-10)
Time frame: 9 months
Scale To Assess Therapeutic Relationships - Patient Version (STAR-P)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2020.
- Derived from this study: PubMed 38241785D'Arcey JN, Zhao H, Wang W, Voineskos AN, Kozloff N, Kidd SA, Foussias G. An SMS text messaging intervention to improve clinical engagement in early psychosis: A pilot randomized-controlled trial. Schizophr Res. 2024 Feb;264:416-423. doi: 10.1016/j.schres.2024.01.012. Epub 2024 Jan 18.
- Individual participant dataSharing planned: No
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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.
George Foussias, MD PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS text messaging - interactive check-in in people with Psychotic Disorders, 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 8 May 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Service Engagement Scale (SES) (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04379349, which also lists 1 linked publication.
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 8 May 2020.