Texting for Relapse Prevention (T4RP)
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|ClinicalTrials.gov Identifier: NCT02819349|
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Behavioral: Texting for Relapse Prevention (T4RP)||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Official Title:||Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD|
|Estimated Study Start Date :||March 12, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
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.
- 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.
- 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.
- 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.
- Institutionalization [ Time Frame: 6-months post-study enrollment ]The number of hospitalizations or ER crisis visits during the study period
- 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
- 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.
- 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.
- 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.
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
|Contact: Michele Ybarraemail@example.com|
|United States, Maryland|
|Johns Hopkins Community Psychiatry Program (JHCPP)||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Bernadette Cullen, MD 410-955-5748|
|Principal Investigator:||Michele Ybarra, PhD||Center for Innovative Public Health Research (CiPHR)|
|Principal Investigator:||Bernadette Cullen, PhD||Johns Hopkins Community Psychiatry Program (JHCPP)|