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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04379349
Other study ID # 091-2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date March 31, 2020

Study information

Verified date May 2020
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years to 29 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- involved in another intervention study

- do not have a personal cell phone number

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SMS text messaging - interactive check-in
Interactive SMS text message check-ins delivered once weekly to participants.
SMS text messaging - inactive control
Minimally interactive SMS text message delivered once weekly to participants.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Service Engagement Scale (SES) Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement) 9 months
Primary Appointment Attendance Percentage of attended clinic appointments 9 months
Secondary Emergency Department Visits Number of emergency department visits 9 months
Secondary Hospitalizations Number of hospitalizations 9 months
Secondary Social Functioning Scale (SFS) Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning) 9 months
Secondary Personal and Social Performance Scale (PSP) Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning) 9 months
Secondary 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) 9 months
Secondary Clinical Global Impression (CGI) Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity) 9 months
Secondary 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) 9 months
Secondary 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) 9 months
Secondary 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) 9 months
Secondary 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) 9 months
Secondary Drug Attitude Inventory (DAI-10) Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence) 9 months
Secondary 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) 9 months
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