Clinical trial NCT02819349: Texting for Relapse Prevention
Official title: Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Relapse Prevention
People with Schizophrenia
Text-Messaging
Assertive Community Treatment (ACT)
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: National Institute of Mental Health (NIMH)
First posted: 2016-06-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: The Positive and Negative Syndrome Scale (PANSS)
timeFrame: 6-months post-study enrollment
measure: Montgomery-Asberg Depression Scale (MADRS)
timeFrame: 6-months post-study enrollment
measure: Young Mania Rating Scale (YMRS)
timeFrame: 6-months post-study enrollment
measure: Institutionalization
timeFrame: 6-months post-study enrollment
measure: Recovery Assessment Scale
timeFrame: 6-months post-study enrollment
Secondary outcomes:
measure: Brief Adherence Rating Scale
timeFrame: 6-months post-intervention
measure: Boston University Empowerment Scale
timeFrame: 6-months post-intervention
measure: Brief Cognitive Assessment
timeFrame: 6-months post-intervention
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Community Psychiatry Program (JHCPP)
state: Maryland
Study officials:
affiliation: Center for Innovative Public Health Research (CiPHR)
name: Michele Ybarra, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Community Psychiatry Program (JHCPP)
name: Bernadette Cullen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.