Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia
Recruitment status was Recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Culturally Based Family Therapy for Schizophrenia |
- Schizophrenia symptom severity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
- 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 |
|---|---|
|
Experimental: 1
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.
|
|
Active Comparator: 2
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 |
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| 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
Publications:
| Responsible Party: | Amy G. Weisman de Mamani, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00356317 History of Changes |
| Other Study ID Numbers: | R34 MH071250, DSIR 83-ATAP |
| Study First Received: | July 21, 2006 |
| Last Updated: | March 23, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Culture Family Therapy |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013