Texting for Relapse Prevention

NCT02819349 | Completed

• 1 other identifier: 1R34MH108781
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Relapse Prevention; People with Schizophrenia; Text-Messaging; Assertive Community Treatment (ACT)

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Institutionalization

  The number of hospitalizations or ER crisis visits during the study period

  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

  6-months post-study enrollment

Secondary Outcomes (3)

• Brief Adherence Rating Scale

  6-months post-intervention

• Boston University Empowerment Scale

  6-months post-intervention

• Brief Cognitive Assessment

  6-months post-intervention

Study Arms (2)

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.

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.

Interventions

Texting for Relapse Prevention (T4RP) BEHAVIORAL

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.

Texting for Relapse Prevention (T4RP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• have at least one of their providers consent to take part in the study

Sponsors & Collaborators

• Center for Innovative Public Health Research: lead
• Johns Hopkins University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins Community Psychiatry Program (JHCPP)

Baltimore, Maryland, 21287, United States

Location

Related 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.

  PMID: 31503175 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Michele Ybarra, PhD

  Center for Innovative Public Health Research (CiPHR)

  PRINCIPAL INVESTIGATOR

• Bernadette Cullen, PhD

  Johns Hopkins Community Psychiatry Program (JHCPP)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: March 12, 2018
• Primary Completion: April 9, 2019
• Study Completion: April 9, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

US (1)