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Using Short Message Service as a Means of Clinical Engagement in Early Psychosis

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SMS text messaging - interactive check-in
SMS text messaging - inactive control
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring SMS text messaging, Clinical engagement

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active SMS

Sham SMS

Arm Description

Weekly interactive SMS text messaging check-ins.

Weekly minimally interactive SMS text messages.

Outcomes

Primary Outcome Measures

Service Engagement Scale (SES)
Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)
Appointment Attendance
Percentage of attended clinic appointments

Secondary Outcome Measures

Emergency Department Visits
Number of emergency department visits
Hospitalizations
Number of hospitalizations
Social Functioning Scale (SFS)
Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning)
Personal and Social Performance Scale (PSP)
Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning)
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)
Clinical Global Impression (CGI)
Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity)
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)
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)
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)
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)
Drug Attitude Inventory (DAI-10)
Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence)
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)

Full Information

First Posted
May 5, 2020
Last Updated
May 6, 2020
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04379349
Brief Title
Using Short Message Service as a Means of Clinical Engagement in Early Psychosis
Official Title
Using Short Message Service as a Means of Clinical Engagement in Early Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
SMS text messaging, Clinical engagement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active SMS
Arm Type
Experimental
Arm Description
Weekly interactive SMS text messaging check-ins.
Arm Title
Sham SMS
Arm Type
Sham Comparator
Arm Description
Weekly minimally interactive SMS text messages.
Intervention Type
Behavioral
Intervention Name(s)
SMS text messaging - interactive check-in
Intervention Description
Interactive SMS text message check-ins delivered once weekly to participants.
Intervention Type
Behavioral
Intervention Name(s)
SMS text messaging - inactive control
Intervention Description
Minimally interactive SMS text message delivered once weekly to participants.
Primary Outcome Measure Information:
Title
Service Engagement Scale (SES)
Description
Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)
Time Frame
9 months
Title
Appointment Attendance
Description
Percentage of attended clinic appointments
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Emergency Department Visits
Description
Number of emergency department visits
Time Frame
9 months
Title
Hospitalizations
Description
Number of hospitalizations
Time Frame
9 months
Title
Social Functioning Scale (SFS)
Description
Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning)
Time Frame
9 months
Title
Personal and Social Performance Scale (PSP)
Description
Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning)
Time Frame
9 months
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)
Description
Self-reported measure of subjective quality of life (minimum score = 1, maximum score = 5, higher score indicates better quality of life)
Time Frame
9 months
Title
Clinical Global Impression (CGI)
Description
Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity)
Time Frame
9 months
Title
Brief Psychiatric Rating Scale (BPRS)
Description
Interview-based measure of the severity of psychiatric symptoms (minimum score = 24, maximum score = 168, higher score indicates higher severity of symptoms)
Time Frame
9 months
Title
Scale for the Assessment of Negative Symptoms (SANS)
Description
Interview-based measure of the severity of negative symptoms (minimum score = 0, maximum score = 110, higher score indicates higher severity of symptoms)
Time Frame
9 months
Title
Apathy Evaluation Scale (AES)
Description
Interview-rated measure of the severity of motivation deficits (minimum score = 18, maximum score = 72, higher score indicates worse motivation deficits)
Time Frame
9 months
Title
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Description
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)
Time Frame
9 months
Title
Drug Attitude Inventory (DAI-10)
Description
Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence)
Time Frame
9 months
Title
Scale To Assess Therapeutic Relationships - Patient Version (STAR-P)
Description
Self-reported measure of the clinician-patient therapeutic relationship (minimum score = 0, maximum score = 48, higher score indicates better therapeutic relationship)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Foussias, MD PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Using Short Message Service as a Means of Clinical Engagement in Early Psychosis

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