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

NCT ID: NCT00356317

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-03-31

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.

Conditions

Schizophrenia

Keywords

Culture; Family; Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Participants will receive a 15-week family therapy

Group Type: EXPERIMENTAL

Culturally informed therapy for schizophrenia (CIT-S)

Intervention Type: BEHAVIORAL

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.

2

Participants will receive a 3-week family therapy (treatment as usual)

Group Type: ACTIVE_COMPARATOR

Psychoeducation treatment as usual

Intervention Type: BEHAVIORAL

This family therapy consists of three weekly sessions focusing on education about schizophrenia.

Interventions

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.

Intervention Type: BEHAVIORAL

Psychoeducation treatment as usual

This family therapy consists of three weekly sessions focusing on education about schizophrenia.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Amy Weisman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Weisman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Coral Gables, Florida, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16768017 (View on PubMed)

Other Identifiers

R34MH071250

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 83-ATAP

Identifier Type: -

Identifier Source: secondary_id

R34MH071250

Identifier Type: NIH

Identifier Source: org_study_id

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