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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Amy Weisman, University of Miami
ClinicalTrials.gov Identifier:
NCT00356317
First received: July 21, 2006
Last updated: December 17, 2015
Last verified: December 2015
July 21, 2006
December 17, 2015
March 2015
March 2015   (Final data collection date for primary outcome measure)
Schizophrenia symptom severity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
  • Schizophrenia symptom severity
  • Depression, anxiety, and quality of life
  • Family functioning
  • Cultural identity
  • Coping styles
  • Religiosity
  • Alcohol and drug use
  • Knowledge and attitudes about schizophrenia (all measured post-treatment and at Months 6 and 12)
Complete list of historical versions of study NCT00356317 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
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Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia
A Culturally Based Family Therapy for Schizophrenia
This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with 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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • Behavioral: Psychoeducation treatment as usual
    This family therapy consists of three weekly sessions focusing on education about schizophrenia.
  • Experimental: 1
    Participants will receive a 15-week family therapy
    Intervention: Behavioral: Culturally informed therapy for schizophrenia (CIT-S)
  • Active Comparator: 2
    Participants will receive a 3-week family therapy (treatment as usual)
    Intervention: Behavioral: Psychoeducation treatment as usual
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
March 2015
March 2015   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00356317
R34MH071250
R34MH071250 ( US NIH Grant/Contract Award Number )
DSIR 83-ATAP
Yes
Not Provided
Not Provided
Not Provided
Amy Weisman, University of Miami
University of Miami
National Institute of Mental Health (NIMH)
Principal Investigator: Amy Weisman, PhD University of Miami
University of Miami
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP