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Texting for Relapse Prevention (T4RP)

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ClinicalTrials.gov Identifier: NCT02819349
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : August 23, 2018
Sponsor:
Collaborators:
Johns Hopkins University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Center for Innovative Public Health Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Texting for Relapse Prevention (T4RP) Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Texting for Relapse Prevention (T4RP)
T4RP is a relapse prevention mHealth program text messaging to people who have schizophrenia/SAD. The intervention will include an online interface for clinicians and an automated text messaging program for patients. Firstly, patients and providers will meet in an intake session, to identify the patient's personal early warning signs from a pre-identified list. Using the online interface, providers will enter additional warning signs or personalize the wording of the messages as requested by the patient. The patient also will determine the threshold at which the provider will be alerted about a possible relapse and whether additional contact people should be alerted.
Behavioral: Texting for Relapse Prevention (T4RP)
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.

No Intervention: Treatment-As-Usual Control
The control group will be a treatment as usual comparison group. For the majority of individuals with schizophrenia/SAD in care at JHCPP, this involves 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. All routine appointments are scheduled, but individuals can walk in or call if they do not feel well between sessions.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819349


Contacts
Contact: Michele Ybarra 8773026858 michele@innovativepublichealth.org

Locations
United States, Maryland
Johns Hopkins Community Psychiatry Program (JHCPP) Recruiting
Baltimore, Maryland, United States, 21287
Contact: Bernadette Cullen, MD    410-955-5748      
Sponsors and Collaborators
Center for Innovative Public Health Research
Johns Hopkins University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Michele Ybarra, PhD Center for Innovative Public Health Research (CiPHR)
Principal Investigator: Bernadette Cullen, PhD Johns Hopkins Community Psychiatry Program (JHCPP)

Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT02819349     History of Changes
Other Study ID Numbers: 1R34MH108781 ( U.S. NIH Grant/Contract )
1R34MH108781 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Center for Innovative Public Health Research:
Relapse Prevention
People with Schizophrenia
Text-Messaging
Assertive Community Treatment (ACT)

Additional relevant MeSH terms:
Schizophrenia
Recurrence
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes