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Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00356317
  Purpose

This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.


Condition Intervention Phase
Schizophrenia
Behavioral: Culturally informed therapy for schizophrenia (CIT-S)
Behavioral: Psychoeducation treatment as usual
Phase II

MedlinePlus related topics:   Schizophrenia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   A Culturally Based Family Therapy for Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Schizophrenia symptom severity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms of depression, anxiety, and stress [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Family functioning [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Cultural Identity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Coping styles [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Religiosity/Spirituality [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Alcohol and Drug Use [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • Knowledge and knowledge about schizophrenia [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:   180
Study Start Date:   April 2004
Estimated Study Completion Date:   May 2010
Estimated Primary Completion Date:   May 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants will receive a 15-week family therapy
Behavioral: Culturally informed therapy for schizophrenia (CIT-S)
This family therapy consists of 15 video-taped, therapy sessions, each lasting approximately 75 minutes. The 15-session treatment will be broken down into five segments (each lasting approximately three sessions) with the following goals: 1) Fortify a strong sense of family unity; 2) educate about schizophrenia; 3) foster adaptive use of cultural, spiritual and/or existential beliefs in conceptualizing and coming to terms with schizophrenia; 4) teach effective communication training techniques; and 5) and teach useful problem solving strategies.
2: Active Comparator
Participants will receive a 3-week family therapy (treatment as usual)
Behavioral: Psychoeducation treatment as usual
This family therapy consists of three weekly sessions focusing on education about schizophrenia.

Detailed Description:

Schizophrenia is a disabling mental disorder that affects approximately 1% of the population worldwide. People with schizophrenia frequently experience hallucinations, delusions, disordered thinking, movement disorders, emotional numbness, social withdrawal, and cognitive deficits. These symptoms can hinder a person's ability to perform everyday functions, such as hold a job and maintain normal social relationships. When combined with medication, family-oriented therapy interventions have been beneficial for people with schizophrenia. There are few programs, however, that are tailored to the needs of minorities. With the rising number of minority populations in the U.S., it is important to develop psychotherapy interventions that are designed specifically for these groups. This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

Participants in this 12-month, open label study will first attend a 2-hour screening visit, at which information will be gathered regarding coping styles, spirituality, and expressed emotion. Participants will then be randomly assigned to receive either culturally based therapy or treatment as usual. Although the culturally based therapy will be tailored to the needs and values of Hispanics, people who are not Hispanic will not be excluded. The culturally based therapy will entail 15 weekly therapy sessions, which will focus on family unity, psychoeducation, spirituality, communication skills, and problem-solving. The group receiving treatment as usual will attend 3 weekly psychoeducation sessions that will focus on informing participants about schizophrenia. Outcomes for both groups will be assessed upon completion of treatment and at follow-up visits at Months 6 and 12.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

For participants with schizophrenia or schizoaffective disorder:

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Currently taking medication
  • 18 or older

For all participants:

  • Two or more family members, including patient, are available for participation (therapy can be conducted if patient is not available, as long as two other family members are interested in participating)
  • Family members must be at least 13 years old

Exclusion Criteria:

  • N/A
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356317

Contacts
Contact: Amy Weisman, PhD     305-284-5455     aweisman@miami.edu    
Contact: Radha Dunham     305-284-5455     rdunham@psy.miami.edu    

Locations
United States, Florida
University of Miami     Recruiting
      Coral Gables, Florida, United States, 33146
      Sub-Investigator: Radha Dunham            
      Sub-Investigator: Eugenio Duarte            
      Sub-Investigator: Vamsi Koneru            
      Sub-Investigator: Stephanie Wasserman            
      Principal Investigator: Amy Weisman, PhD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Amy Weisman, PhD     University of Miami    
  More Information


Publications:

Responsible Party:   University of Miami ( Amy G. Weisman de Mamani )
Study ID Numbers:   R34 MH71250, DSIR 83-ATAP
First Received:   July 21, 2006
Last Updated:   August 19, 2008
ClinicalTrials.gov Identifier:   NCT00356317
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Culture  
Family  
Therapy  

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 19, 2008




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