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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amy Weisman, University of Miami
ClinicalTrials.gov Identifier:
NCT00356317
First received: July 21, 2006
Last updated: May 28, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by University of Miami:

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: September 2015
Estimated Primary Completion Date: May 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356317

Locations
United States, Florida
University of Miami
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
University of Miami
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: R34 MH071250, R34MH071250, DSIR 83-ATAP
Study First Received: July 21, 2006
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Miami:
Culture
Family
Therapy

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014