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

NCT00356317 | Completed Phase 2 DMC

• 2 other identifiers: R34MH071250DSIR 83-ATAP
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Keywords

Culture; Family; Therapy

Outcome Measures

Primary Outcomes (1)

• Schizophrenia symptom severity

  Measured immediately post-treatment and at Months 6 and 12

Secondary Outcomes (7)

• 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

Study Arms (2)

1

EXPERIMENTAL

Participants will receive a 15-week family therapy

Behavioral: Culturally informed therapy for schizophrenia (CIT-S)

2

ACTIVE COMPARATOR

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

Behavioral: Psychoeducation treatment as usual

Interventions

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.

1

Psychoeducation treatment as usual BEHAVIORAL

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

2

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For participants with schizophrenia or schizoaffective disorder:
• Diagnosis of schizophrenia or schizoaffective disorder
• Currently taking medication
• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (1)

• 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.

  PMID: 16768017 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Amy Weisman, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 21, 2006
• First Posted: July 25, 2006
• Study Start: March 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

US (1)