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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00356317
First received: July 21, 2006
Last updated: March 23, 2009
Last verified: March 2009

July 21, 2006
March 23, 2009
April 2004
May 2010   (final data collection date for primary outcome measure)
Schizophrenia symptom severity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ 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 ]
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Efficacy Study
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.
 
Recruiting
180
May 2010
May 2010   (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:

  • N/A
Both
13 Years and older
Yes
Contact: Amy Weisman, PhD 305-284-5455 aweisman@miami.edu
Contact: Radha Dunham 305-284-5455 rdunham@psy.miami.edu
United States
 
NCT00356317
R34 MH071250, DSIR 83-ATAP
Yes
Amy G. Weisman de Mamani, University of Miami
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Amy Weisman, PhD University of Miami
National Institute of Mental Health (NIMH)
March 2009

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