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

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University of Miami

Status and phase

Completed
Phase 2

Conditions

Schizophrenia

Treatments

Behavioral: Psychoeducation treatment as usual
Behavioral: Culturally informed therapy for schizophrenia (CIT-S)

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00356317
DSIR 83-ATAP
R34MH071250 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

Full 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.

Enrollment

400 patients

Sex

All

Ages

13+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

1
Experimental group
Description:
Participants will receive a 15-week family therapy
Treatment:
Behavioral: Culturally informed therapy for schizophrenia (CIT-S)
2
Active Comparator group
Description:
Participants will receive a 3-week family therapy (treatment as usual)
Treatment:
Behavioral: Psychoeducation treatment as usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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