Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia - Full Text View

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.

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Amy Weisman, PhD

University of Miami

More Information

Publications:

Weisman A, Duarte E, Koneru V, Wasserman S. The development of a culturally informed, family-focused treatment for schizophrenia. Fam Process. 2006 Jun;45(2):171-86.

Responsible Party:	University of Miami ( Amy G. Weisman de Mamani )
Study ID Numbers:	R34 MH71250, DSIR 83-ATAP
Study 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 January 30, 2009