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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Culturally informed therapy for schizophrenia (CIT-S); Behavioral: Psychoeducation treatment as usual

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Schizophrenia symptom severity	Measured immediately post-treatment and at Months 6 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptoms of depression, anxiety, and stress	Measured immediately post-treatment and at Months 6 and 12
Family functioning	Measured immediately post-treatment and at Months 6 and 12
Cultural Identity	Measured immediately post-treatment and at Months 6 and 12
Coping styles	Measured immediately post-treatment and at Months 6 and 12
Religiosity/Spirituality	Measured immediately post-treatment and at Months 6 and 12
Alcohol and Drug Use	Measured immediately post-treatment and at Months 6 and 12
Knowledge and knowledge about schizophrenia	Measured immediately post-treatment and at Months 6 and 12

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Amy Weisman, PhD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: July 21, 2006
• First Submitted That Met QC Criteria: July 21, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Family; Therapy; Culture
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: R34MH071250 (U.S. NIH Grant/Contract); DSIR 83-ATAP (NIMH/DSIR)