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OpenTrials
Completed

NCT Number: NCT02819349

Texting for Relapse Prevention

The purpose of this study is to examine whether Texting for Relapse Prevention (T4RP), a text messaging-based early warming for relapse prevention in people who have schizophrenia/SAD, is associated with fewer relapse symptoms compared to a treatment-as-usual control group.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Community Psychiatry Program (JHCPP)

Baltimore, Maryland, 21287, United States

About this study

Schizophrenia is among the 20 most debilitating illnesses worldwide, responsible for 1% of the global burden of disease. Schizoaffective disorder (SAD) affects an additional 0.2% to 1.1% of adults. As many as four out of five people who have schizophrenia or SAD relapse within 5 years of recovery from their initial episode. Interventions aimed at early intervention to prevent relapse would impact public health.

The Texting for Relapse Prevention (T4RP) is an innovative service delivery program delivered via text messaging designed for people who have schizophrenia/SAD. The intervention will be tested in a randomized controlled trial against a treatment-as-usual control group which, for most, involved meeting with their therapist every 2 to 4 weeks and meeting with their psychiatrist at least once every 90 days or more frequently as clinically indicated. A total of 40 people with schizophrenia and 5-15 provider participants (depending on the patient distribution across the providers) in the pilot RTC. The study is being conducted by researchers at the Center for Innovative Public Health Research and Johns Hopkins Community Psychiatry Program (JHCPP).

The investigators posit that T4RP will reduce psychiatric morbidity and institutionalization rates and promote recovery by facilitating improved patient-provider communication, promoting medication adherence, helping people self-monitor their early warning signs, and promoting self-management of symptoms.

If T4RP is effective, this cost-effective and easily scalable intervention will make a significant public health impact and reduction in relapse-related costs for people with schizophrenia/SAD.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • be English-speaking;
  • have a chart diagnosis of schizophrenia or SAD
  • be able to provide consent (i.e., pass the Capacity to Consent screen)
  • own a cell phone and report using the text messaging function
  • be currently at their personal baseline with regard to symptoms and functioning as assessed by their provider (i.e., not in relapse and compliant with treatment)
  • be actively under the care of a mental health provider enrolled in the program
  • agree to continue attending the clinic for the duration of the study
  • plan to keep the same cell phone number for the duration of the study
  • have at least one of their providers consent to take part in the study

Exclusion criteria

  • have at least one of their providers consent to take part in the study

Treatment and study plan

Texting for Relapse Prevention (T4RP)

Behavioral

T4RP is a relapse prevention mHealth program text messaging to people who have schizophrenia/SAD. Content is guided by components of the Assertive Community Treatment (ACT) and focuses on facilitating improved patient-provider communication, promoting medication adherence, helping people self-monitor their early warning signs, and promoting self-management of symptoms.

Primary outcomes

  1. The Positive and Negative Syndrome Scale (PANSS)

    Time frame: 6-months post-study enrollment

    It has three subscales that measure: positive symptoms of schizophrenia, negative symptoms of schizophrenia, and general psychopathology.

  2. Montgomery-Asberg Depression Scale (MADRS)

    Time frame: 6-months post-study enrollment

    It is a clinician-administered 10-item scale developed to measure changes in depressive symptom during treatment.

  3. Young Mania Rating Scale (YMRS)

    Time frame: 6-months post-study enrollment

    It is is an 11-item clinician administered scale that assesses the presence and severity of manic symptoms.

  4. Institutionalization

    Time frame: 6-months post-study enrollment

    The number of hospitalizations or ER crisis visits during the study period

  5. Recovery Assessment Scale

    Time frame: 6-months post-study enrollment

    It is a 41-item self-report scale with 5 subscales that measure an individual's experience of recovery

Secondary outcomes

  1. Brief Adherence Rating Scale

    Time frame: 6-months post-intervention

    It is a clinician-administered, 4-item scale that has three questions and an overall visual analog scale. It was designed for use in community settings with individuals who have schizophrenia or schizoaffective disorder and has been validated against electronically-monitored adherence.

  2. Boston University Empowerment Scale

    Time frame: 6-months post-intervention

    It is a 28-item self-report scale that measures empowerment among those using mental health services.

  3. Brief Cognitive Assessment

    Time frame: 6-months post-intervention

    It is a clinician administered test that consists of 3 standard tests: Verbal Fluency, Hopkins Verbal Learning Test and Trails A and B and has been shown to be related to measures of functional outcome in patients with schizophrenia.

Sponsors and collaborators

Lead sponsor

Center for Innovative Public Health Research

Other

Collaborators

  • Johns Hopkins University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD

Acronym: T4RP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 30, 2016
Registry last updated
Feb 20, 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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