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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Culturally informed therapy for schizophrenia (CIT-S)
Psychoeducation treatment as usual
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Culture, Family, Therapy

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive a 15-week family therapy

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

Outcomes

Primary Outcome Measures

Schizophrenia symptom severity

Secondary Outcome Measures

Symptoms of depression, anxiety, and stress
Family functioning
Cultural Identity
Coping styles
Religiosity/Spirituality
Alcohol and Drug Use
Knowledge and knowledge about schizophrenia

Full Information

First Posted
July 21, 2006
Last Updated
December 17, 2015
Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00356317
Brief Title
Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia
Official Title
A Culturally Based Family Therapy for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Culture, Family, Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive a 15-week family therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive a 3-week family therapy (treatment as usual)
Intervention Type
Behavioral
Intervention Name(s)
Culturally informed therapy for schizophrenia (CIT-S)
Intervention Description
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
Intervention Name(s)
Psychoeducation treatment as usual
Intervention Description
This family therapy consists of three weekly sessions focusing on education about schizophrenia.
Primary Outcome Measure Information:
Title
Schizophrenia symptom severity
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Secondary Outcome Measure Information:
Title
Symptoms of depression, anxiety, and stress
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Title
Family functioning
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Title
Cultural Identity
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Title
Coping styles
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Title
Religiosity/Spirituality
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Title
Alcohol and Drug Use
Time Frame
Measured immediately post-treatment and at Months 6 and 12
Title
Knowledge and knowledge about schizophrenia
Time Frame
Measured immediately post-treatment and at Months 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Weisman, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16768017
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.
Results Reference
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Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia

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