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Completed

NCT Number: NCT00356317

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

This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culturally informed therapy for schizophrenia (CIT-S)

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.

Psychoeducation treatment as usual

Behavioral

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

Primary outcomes

  1. Schizophrenia symptom severity

    Time frame: Measured immediately post-treatment and at Months 6 and 12

Secondary outcomes

  1. Symptoms of depression, anxiety, and stress

    Time frame: Measured immediately post-treatment and at Months 6 and 12

  2. Family functioning

    Time frame: Measured immediately post-treatment and at Months 6 and 12

  3. Cultural Identity

    Time frame: Measured immediately post-treatment and at Months 6 and 12

  4. Coping styles

    Time frame: Measured immediately post-treatment and at Months 6 and 12

  5. Religiosity/Spirituality

    Time frame: Measured immediately post-treatment and at Months 6 and 12

  6. Alcohol and Drug Use

    Time frame: Measured immediately post-treatment and at Months 6 and 12

  7. Knowledge and knowledge about schizophrenia

    Time frame: Measured immediately post-treatment and at Months 6 and 12

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Culturally Based Family Therapy for Schizophrenia

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2006
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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