Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
461 participants
INTERVENTIONAL
2013-04-30
2015-06-30
Brief Summary
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Detailed Description
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The components of the HTP program that are being tested in the pilot program include: 1) evidence-based pharmacological treatment facilitated by a web-based prescriber decision support system-Prescriber Decision Assistant (PDA) 2) brief, in-person, relapse prevention counseling with supplemental web-based learning modules, 3) a daily support website that offers web- and phone-based resources to support persons with schizophrenia and their family members or others. The resources include a patient and family Psycho-Education Treatment program, which includes electronic peer groups facilitated by mental health professionals, providing medication reminders via web and phone, and conducting monitoring of early warning signs of relapse via web and phone 4) an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia 5) a web-based, self-administered cognitive-behavioral therapy (CBT) program for the management of hallucinations. All patients will be provided with pharmacological treatment (PDA), brief in-person relapse prevention counseling, and an Android mobile phone. The other program components will be provided to patients using a shared decision-making approach to assess need and preference.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Health Technology Program
The components of the treatment model include: 1) Prescriber Decision Assistant (PDA) 2) relapse prevention plan, 3) the daily support website 4) FOCUS, an interactive smart phone text-messaging application 5) a web-based, cognitive-behavioral therapy (CBT) program
All patients will be provided with pharmacological treatment (PDA), brief in-person relapse prevention counseling, and an Android mobile phone. The other program components will be provided to patients using a shared decision-making approach to assess need and preference.
Relapse Prevention Plan
brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
Daily Support Website
web-based program for patients and families that provides psychoeducation about schizophrenia and its treatments to improve knowledge, increase problem-solving skills and offer social support through the use of web-based therapist facilitated sessions
Computer CBT for voices and paranoia
A ten-session CBT programs, one to address voices and the other for paranoia. The web-based programs incorporate the essential elements of CBT for psychosis such as normalizing behavior and offering behavioral coping strategies
FOCUS
an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia
Prescriber Decision Assistant
is a web-based prescriber decision support system that includes a brief patient-completed assessment describing symptoms and adverse events which prompts the prescriber to conduct a detailed clinical assessment. Embedded in the program are decision supports for medication choices based on best evidence-based practices regarding symptoms, side effects, information from laboratory tests and history of prior treatment response
Interventions
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Relapse Prevention Plan
brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
Daily Support Website
web-based program for patients and families that provides psychoeducation about schizophrenia and its treatments to improve knowledge, increase problem-solving skills and offer social support through the use of web-based therapist facilitated sessions
Computer CBT for voices and paranoia
A ten-session CBT programs, one to address voices and the other for paranoia. The web-based programs incorporate the essential elements of CBT for psychosis such as normalizing behavior and offering behavioral coping strategies
FOCUS
an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia
Prescriber Decision Assistant
is a web-based prescriber decision support system that includes a brief patient-completed assessment describing symptoms and adverse events which prompts the prescriber to conduct a detailed clinical assessment. Embedded in the program are decision supports for medication choices based on best evidence-based practices regarding symptoms, side effects, information from laboratory tests and history of prior treatment response
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of:
* schizophrenia
* schizoaffective disorder
* psychosis NOS
* Has had two or more inpatient hospitalizations for treatment of a psychotic disorder
* Currently in the hospital or up to 30 days of inpatient hospitalization for a psychotic disorder
o If patients are sent to a partial, or day hospital following an inpatient hospitalization, the 30 day window begins at the time of discharge from the day or partial hospital
* Any ethnicity
* Ability to participate in research assessments in English
* Ability to provide fully informed consent
Exclusion Criteria
* More than 30 days since discharge from a psychiatric hospitalization
* Any other serious medical condition that in the opinion of the investigator would seriously impair functioning making the patient unsuitable for the trial
* Patients who would likely find it burdensome and/or have difficulty sustaining the use of a laptop computer and /or smart phone due to issues of security, consistent connectivity or other factors.
18 Years
60 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Boston University
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Northwell Health
OTHER
Responsible Party
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John Kane
Senior Vice President, Behavioral Health Services
Principal Investigators
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John Kane
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Henderson Mental Health Center
Fort Lauderdale, Florida, United States
Community Mental Health Center, Inc.
Lawrenceburg, Indiana, United States
Cherry Street
Grand Rapids, Michigan, United States
UMKC School of Pharmacy
Kansas City, Missouri, United States
Burrell Behavioral Health
Springfield, Missouri, United States
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States
University of New Mexico Department of Psychiatry UNM Health Sciences Center
Albuquerque, New Mexico, United States
PeaceHealth Oregon/Lane County Behavioral Health Services
Eugene, Oregon, United States
Countries
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Other Identifiers
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ICRC
Identifier Type: -
Identifier Source: org_study_id
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