Clinical trial NCT02600741: Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
Official title: A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Caregiver
Psycho-education and skills training
Paliperidone Palmitate
Oral Antipsychotic
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2015-11-09
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of a paired patient and caregiver. A caregiver is defined as a person who has accepted responsibility for providing the patient with both assistance with activities of daily living and protection from harm. The patient will have a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder.

Brief summary: The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatment failures (psychiatric hospitalization, psychiatric emergency room (ER) visit, crisis center visit, mobile crisis unit intervention, arrest/incarceration, and suicide or suicide attempt) in patients under their care during a 12 month period.

Detailed description: This is a randomized, open-label, parallel group study of patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder and their caregivers. Study will consist of a paired patient and caregiver. Patients will receive routine treatment, which may include oral antipsychotics or paliperidone palmitate, as directed by their treating physician. Caregivers for patients whose routine treatment is paliperidone palmitate will be randomized to receive either a study-provided caregiver psycho-education and skills training or usual caregiver support. Caregivers for patients whose routine treatment is oral antipsychotics will be randomized to the same Study Groups: Study Group 1: Study-provided caregiver psycho-education and skills training. Study Group 2: Usual caregiver support (caregiver support that is customarily provided by the study site, if any). Patients-caregiver pairs will be followed for up to 12 months following baseline assessment. Cumulative number of treatment failures over 12 months will be assessed primarily.

Eligibility criteria: Inclusion Criteria:

A) Caregivers

* Each caregiver must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate for the duration of the study
* Caregiver is able to have verbal interaction with the patient with schizophrenia, schizoaffective disorder, or schizophreniform disorder at least twice a week, per self-report

B) Patients

* Patients must have a clinical diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria for these disorders
* Patients must be receiving ongoing psychiatric treatment at the study site and must be receiving oral antipsychotics or paliperidone palmitate long acting therapy

Exclusion Criteria:

* A) Caregivers
* Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by the treatment team
* Caregiver has received structured or manualized psycho-education or skills training within 1 year prior to Screening B) Patients
* Patient is hospitalized (medical or psychiatric), incarcerated, or otherwise institutionalized at time of randomization
* Patient is considered to have significant potential for imminent harm to self and/or others as based on the judgment of the treatment team
* Patient is receiving assertive community treatment (ACT) or other high intensity case management services to prevent hospitalization

Primary outcomes:
measure: Number of Treatment Failures Over 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Caregiver Burden Based on Involvement Evaluation Questionnaire (IEQ) Total Score at Month 12
timeFrame: Month 12
measure: Number of Treatment Failures in Patients Taking Oral Antipsychotics
timeFrame: 12 months
measure: Number of Treatment Failures in Patients Taking Paliperidone Palmitate
timeFrame: 12 months
measure: Patient Recovery Based on Total Illness Management and Recovery (IMR) Score
timeFrame: Month 6 and Month 12
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) at Month 12
timeFrame: Month 12
measure: Change From Baseline in 12- Item Short Form Health Survey (SF-12) at Month 12
timeFrame: Month 12
Other outcomes:
Locations:
city: Bullhead City
country: United States
state: Arizona
city: Oceanside
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Farmington
country: United States
state: Connecticut
city: Lauderdale Lakes
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Granite City
country: United States
state: Illinois
city: Lombard
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Bloomington
country: United States
state: Indiana
city: Lawrenceburg
country: United States
state: Indiana
city: Ann Arbor
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Mount Pleasant
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Toledo
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Lincoln
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Richland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_CHAIR
References:
citation: Mueser KT, Achtyes ED, Gogate J, Mancevski B, Kim E, Starr HL. Telehealth-Based Psychoeducation for Caregivers: The Family Intervention in Recent-Onset Schizophrenia Treatment Study. JMIR Ment Health. 2022 Apr 15;9(4):e32492. doi: 10.2196/32492.