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Texting for Relapse Prevention (T4RP)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Texting for Relapse Prevention (T4RP)
Sponsored by
Center for Innovative Public Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Relapse Prevention, People with Schizophrenia, Text-Messaging, Assertive Community Treatment (ACT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Johns Hopkins Community Psychiatry Program (JHCPP)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Texting for Relapse Prevention (T4RP)

Treatment-As-Usual Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Positive and Negative Syndrome Scale (PANSS)
It has three subscales that measure: positive symptoms of schizophrenia, negative symptoms of schizophrenia, and general psychopathology.
Montgomery-Asberg Depression Scale (MADRS)
It is a clinician-administered 10-item scale developed to measure changes in depressive symptom during treatment.
Young Mania Rating Scale (YMRS)
It is is an 11-item clinician administered scale that assesses the presence and severity of manic symptoms.
Institutionalization
The number of hospitalizations or ER crisis visits during the study period
Recovery Assessment Scale
It is a 41-item self-report scale with 5 subscales that measure an individual's experience of recovery

Secondary Outcome Measures

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.
Boston University Empowerment Scale
It is a 28-item self-report scale that measures empowerment among those using mental health services.
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.

Full Information

First Posted
June 28, 2016
Last Updated
February 18, 2020
Sponsor
Center for Innovative Public Health Research
Collaborators
Johns Hopkins University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02819349
Brief Title
Texting for Relapse Prevention
Acronym
T4RP
Official Title
Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
April 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Innovative Public Health Research
Collaborators
Johns Hopkins University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Relapse Prevention, People with Schizophrenia, Text-Messaging, Assertive Community Treatment (ACT)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Texting for Relapse Prevention (T4RP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment-As-Usual Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Texting for Relapse Prevention (T4RP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Positive and Negative Syndrome Scale (PANSS)
Description
It has three subscales that measure: positive symptoms of schizophrenia, negative symptoms of schizophrenia, and general psychopathology.
Time Frame
6-months post-study enrollment
Title
Montgomery-Asberg Depression Scale (MADRS)
Description
It is a clinician-administered 10-item scale developed to measure changes in depressive symptom during treatment.
Time Frame
6-months post-study enrollment
Title
Young Mania Rating Scale (YMRS)
Description
It is is an 11-item clinician administered scale that assesses the presence and severity of manic symptoms.
Time Frame
6-months post-study enrollment
Title
Institutionalization
Description
The number of hospitalizations or ER crisis visits during the study period
Time Frame
6-months post-study enrollment
Title
Recovery Assessment Scale
Description
It is a 41-item self-report scale with 5 subscales that measure an individual's experience of recovery
Time Frame
6-months post-study enrollment
Secondary Outcome Measure Information:
Title
Brief Adherence Rating Scale
Description
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.
Time Frame
6-months post-intervention
Title
Boston University Empowerment Scale
Description
It is a 28-item self-report scale that measures empowerment among those using mental health services.
Time Frame
6-months post-intervention
Title
Brief Cognitive Assessment
Description
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.
Time Frame
6-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Ybarra, PhD
Organizational Affiliation
Center for Innovative Public Health Research (CiPHR)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernadette Cullen, PhD
Organizational Affiliation
Johns Hopkins Community Psychiatry Program (JHCPP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Community Psychiatry Program (JHCPP)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31503175
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.
Results Reference
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Texting for Relapse Prevention

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