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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Culturally Based Family Therapy for Schizophrenia |
| 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.
|
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 |
Inclusion Criteria:
For participants with schizophrenia or schizoaffective disorder:
For all participants:
Exclusion Criteria:
Contacts and Locations| Contact: Amy Weisman, PhD | 305-284-5455 | aweisman@miami.edu |
| Contact: Radha Dunham | 305-284-5455 | rdunham@psy.miami.edu |
| 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 | |
| Principal Investigator: | Amy Weisman, PhD | University of Miami |
More Information
| Responsible Party: | University of Miami ( Amy G. Weisman de Mamani ) |
| Study ID Numbers: | R34 MH071250, DSIR 83-ATAP |
| Study First Received: | July 21, 2006 |
| Last Updated: | March 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00356317 History of Changes |
| Health Authority: | United States: Federal Government |
|
Culture Family Therapy |
|
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
|
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |