Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00356317|
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : December 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Culturally informed therapy for schizophrenia (CIT-S) Behavioral: Psychoeducation treatment as usual||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Culturally Based Family Therapy for Schizophrenia|
|Study Start Date :||March 2015|
|Primary Completion Date :||March 2015|
|Study Completion Date :||March 2015|
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.
- Schizophrenia symptom severity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Symptoms of depression, anxiety, and stress [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Family functioning [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Cultural Identity [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Coping styles [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Religiosity/Spirituality [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Alcohol and Drug Use [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
- Knowledge and knowledge about schizophrenia [ Time Frame: Measured immediately post-treatment and at Months 6 and 12 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356317
|United States, Florida|
|University of Miami|
|Coral Gables, Florida, United States, 33146|
|Principal Investigator:||Amy Weisman, PhD||University of Miami|