Clinical trial NCT00356317: Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia
Official title: A Culturally Based Family Therapy for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Culture
Family
Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-07-25
Enrollment: 400
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with 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 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

Primary outcomes:
measure: Schizophrenia symptom severity
timeFrame: Measured immediately post-treatment and at Months 6 and 12
Secondary outcomes:
measure: Symptoms of depression, anxiety, and stress
timeFrame: Measured immediately post-treatment and at Months 6 and 12
measure: Family functioning
timeFrame: Measured immediately post-treatment and at Months 6 and 12
measure: Cultural Identity
timeFrame: Measured immediately post-treatment and at Months 6 and 12
measure: Coping styles
timeFrame: Measured immediately post-treatment and at Months 6 and 12
measure: Religiosity/Spirituality
timeFrame: Measured immediately post-treatment and at Months 6 and 12
measure: Alcohol and Drug Use
timeFrame: Measured immediately post-treatment and at Months 6 and 12
measure: Knowledge and knowledge about schizophrenia
timeFrame: Measured immediately post-treatment and at Months 6 and 12
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Amy Weisman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1545-5300.2006.00089.x.