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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356317
First Posted: July 25, 2006
Last Update Posted: December 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amy Weisman, University of Miami
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Culturally Based Family Therapy for Schizophrenia

Resource links provided by NLM:


Further study details as provided by Amy Weisman, University of Miami:

Primary Outcome Measures:
  • Schizophrenia symptom severity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]

Secondary Outcome Measures:
  • Symptoms of depression, anxiety, and stress [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Family functioning [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Cultural Identity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Coping styles [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Religiosity/Spirituality [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Alcohol and Drug Use [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Knowledge and knowledge about schizophrenia [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]

Enrollment: 400
Study Start Date: March 2015
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356317


Locations
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
University of Miami
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Amy Weisman, PhD University of Miami
  More Information

Publications:
Responsible Party: Amy Weisman, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT00356317     History of Changes
Other Study ID Numbers: R34MH071250 ( U.S. NIH Grant/Contract )
DSIR 83-ATAP
First Submitted: July 21, 2006
First Posted: July 25, 2006
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Amy Weisman, University of Miami:
Culture
Family
Therapy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders