Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Institutionalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •have at least one of their providers consent to take part in the study
研究组 & 干预措施
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.
干预措施: Texting for Relapse Prevention (T4RP) (Behavioral)
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.
结局指标
主要结局
Institutionalization
时间窗: 6-months post-study enrollment
The number of hospitalizations or ER crisis visits during the study period
The Positive and Negative Syndrome Scale (PANSS)
时间窗: 6-months post-study enrollment
It has three subscales that measure: positive symptoms of schizophrenia, negative symptoms of schizophrenia, and general psychopathology.
Young Mania Rating Scale (YMRS)
时间窗: 6-months post-study enrollment
It is is an 11-item clinician administered scale that assesses the presence and severity of manic symptoms.
Montgomery-Asberg Depression Scale (MADRS)
时间窗: 6-months post-study enrollment
It is a clinician-administered 10-item scale developed to measure changes in depressive symptom during treatment.
Recovery Assessment Scale
时间窗: 6-months post-study enrollment
It is a 41-item self-report scale with 5 subscales that measure an individual's experience of recovery
次要结局
- Boston University Empowerment Scale(6-months post-intervention)
- Brief Adherence Rating Scale(6-months post-intervention)
- Brief Cognitive Assessment(6-months post-intervention)