Texting for Relapse Prevention

Schizophrenia Clinical Trial

— T4RP  

Official title:

Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819349
• Other study ID #: 1R34MH108781
• Secondary ID: 1R34MH108781
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: April 9, 2019

Study information

• Verified date: February 2020
• Source: Center for Innovative Public Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 9, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Recurrence
• Schizoaffective Disorder
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Community Psychiatry Program (JHCPP)	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Center for Innovative Public Health Research	Johns Hopkins University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ybarra ML, Rodriguez K, Madison H, Mojtabai R, Cullen BA. Developing Texting for Relapse Prevention: A Scalable mHealth Program for People With Schizophrenia and Schizoaffective Disorder. J Nerv Ment Dis. 2019 Oct;207(10):854-862. doi: 10.1097/NMD.0000000000001037. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Positive and Negative Syndrome Scale (PANSS)	It has three subscales that measure: positive symptoms of schizophrenia, negative symptoms of schizophrenia, and general psychopathology.	6-months post-study enrollment
Primary	Montgomery-Asberg Depression Scale (MADRS)	It is a clinician-administered 10-item scale developed to measure changes in depressive symptom during treatment.	6-months post-study enrollment
Primary	Young Mania Rating Scale (YMRS)	It is is an 11-item clinician administered scale that assesses the presence and severity of manic symptoms.	6-months post-study enrollment
Primary	Institutionalization	The number of hospitalizations or ER crisis visits during the study period	6-months post-study enrollment
Primary	Recovery Assessment Scale	It is a 41-item self-report scale with 5 subscales that measure an individual's experience of recovery	6-months post-study enrollment
Secondary	Brief Adherence Rating Scale	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.	6-months post-intervention
Secondary	Boston University Empowerment Scale	It is a 28-item self-report scale that measures empowerment among those using mental health services.	6-months post-intervention
Secondary	Brief Cognitive Assessment	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.	6-months post-intervention