SchizophreniaT4RPNCT02819349
Texting for Relapse Prevention
A study testing Texting for Relapse Prevention (T4RP) in people with Schizophrenia and Schizoaffective Disorder, run by Center for Innovative Public Health Research at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Texting for Relapse Prevention (T4RP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2018to 9 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- have at least one of their providers consent to take part in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Community Psychiatry Program (JHCPP)
Baltimore, Maryland, 21287
About this study
Official title: Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Texting for Relapse Prevention (T4RP)
- Keywords
- Relapse Prevention, People with Schizophrenia, Text-Messaging, Assertive Community Treatment (ACT)
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Texting for Relapse Prevention (T4RP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Texting for Relapse Prevention (T4RP) | Experimental | 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. Receives: Behavioral: Texting for Relapse Prevention (T4RP) |
| Treatment-As-Usual Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive and Negative Syndrome Scale (PANSS)
It has three subscales that measure: positive symptoms of schizophrenia, negative symptoms of schizophrenia, and general psychopathology.
Measured: 6-months post-study enrollment
Montgomery-Asberg Depression Scale (MADRS)
It is a clinician-administered 10-item scale developed to measure changes in depressive symptom during treatment.
Measured: 6-months post-study enrollment
Young Mania Rating Scale (YMRS)
It is is an 11-item clinician administered scale that assesses the presence and severity of manic symptoms.
Measured: 6-months post-study enrollment
Institutionalization
The number of hospitalizations or ER crisis visits during the study period
Measured: 6-months post-study enrollment
Recovery Assessment Scale
It is a 41-item self-report scale with 5 subscales that measure an individual's experience of recovery
Measured: 6-months post-study enrollment
Secondary outcomes (3)
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.
Measured: 6-months post-intervention
Boston University Empowerment Scale
It is a 28-item self-report scale that measures empowerment among those using mental health services.
Measured: 6-months post-intervention
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.
Measured: 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start12 Mar 2018
- Primary completion9 Apr 2019
- Study completion9 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Michele Ybarra, PhD, Principal investigator, Center for Innovative Public Health Research (CiPHR)Bernadette Cullen, PhD, Principal investigator, Johns Hopkins Community Psychiatry Program (JHCPP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819349
- Sponsor's protocol ID
- 1R34MH108781
- Other IDs
- 1R34MH108781
- Acronym
- T4RP
- Status last verified
- Feb 2020
- First submitted
- 28 Jun 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31503175
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Texting for Relapse Prevention Among People Diagnosed With Schizophrenia or SAD
- ClinicalTrials.gov ID
- NCT02819349
- Acronym / sponsor ID
- T4RP / 1R34MH108781
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Relapse Prevention, People with Schizophrenia, Text-Messaging, Assertive Community Treatment (ACT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Mental Health (NIMH)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 9 Apr 2019 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Texting for Relapse Prevention (T4RP) | Experimental | Behavioral: 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. |
| Treatment-As-Usual Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (1 listed)
- have at least one of their providers consent to take part in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Texting for Relapse Prevention (T4RP) |
Primary outcome
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
3 secondary outcomes
Brief Adherence Rating Scale
Time frame: 6-months post-intervention
Boston University Empowerment Scale
Time frame: 6-months post-intervention
Brief Cognitive Assessment
Time frame: 6-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 31503175Ybarra 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Ybarra, PhD principal investigator
Center for Innovative Public Health Research (CiPHR)
Bernadette Cullen, PhD principal investigator
Johns Hopkins Community Psychiatry Program (JHCPP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Texting for Relapse Prevention (T4RP) in people with Schizophrenia and Schizoaffective Disorder, run by Center for Innovative Public Health Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive and Negative Syndrome Scale (PANSS) (time frame: 6-months post-study enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02819349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.