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Completed

NCT Number: NCT04379349

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

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.

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Key information

Conditions

Psychotic Disorders Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMS text messaging - interactive check-in

Behavioral

Interactive SMS text message check-ins delivered once weekly to participants.

SMS text messaging - inactive control

Behavioral

Minimally interactive SMS text message delivered once weekly to participants.

Primary outcomes

  1. 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)

  2. Appointment Attendance

    Time frame: 9 months

    Percentage of attended clinic appointments

Secondary outcomes

  1. Emergency Department Visits

    Time frame: 9 months

    Number of emergency department visits

  2. Hospitalizations

    Time frame: 9 months

    Number of hospitalizations

  3. Social Functioning Scale (SFS)

    Time frame: 9 months

    Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning)

  4. Personal and Social Performance Scale (PSP)

    Time frame: 9 months

    Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning)

  5. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)

    Time frame: 9 months

    Self-reported measure of subjective quality of life (minimum score = 1, maximum score = 5, higher score indicates better quality of life)

  6. Clinical Global Impression (CGI)

    Time frame: 9 months

    Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity)

  7. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 9 months

    Interview-based measure of the severity of psychiatric symptoms (minimum score = 24, maximum score = 168, higher score indicates higher severity of symptoms)

  8. Scale for the Assessment of Negative Symptoms (SANS)

    Time frame: 9 months

    Interview-based measure of the severity of negative symptoms (minimum score = 0, maximum score = 110, higher score indicates higher severity of symptoms)

  9. Apathy Evaluation Scale (AES)

    Time frame: 9 months

    Interview-rated measure of the severity of motivation deficits (minimum score = 18, maximum score = 72, higher score indicates worse motivation deficits)

  10. Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)

    Time frame: 9 months

    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)

  11. Drug Attitude Inventory (DAI-10)

    Time frame: 9 months

    Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence)

  12. Scale To Assess Therapeutic Relationships - Patient Version (STAR-P)

    Time frame: 9 months

    Self-reported measure of the clinician-patient therapeutic relationship (minimum score = 0, maximum score = 48, higher score indicates better therapeutic relationship)

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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