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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01786746
Other study ID # R34MH073545
Secondary ID
Status Completed
Phase N/A
First received February 5, 2013
Last updated February 7, 2013
Start date June 2007
Est. completion date March 2011

Study information

Verified date February 2013
Source Claremont McKenna College
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goals of this study were to a) test whether cognitive behavioral therapy (CBT) is effective in treating depressed Chinese Americans, b) to develop and test the effectiveness of culturally adapt CBT, and c) to test the differential outcomes of the two treatments.


Description:

It is now known that ethnic minorities are less likely to receive quality health services and evidence worse treatment outcomes when compared with other groups (IOM, 1999; USDHHS, 2001). Moreover, there continues to be a shortage of systematic investigations examining the efficacy of evidence-based treatments (EBTs) with ethnic minorities, especially among Chinese Americans. Developing interventions that are both empirically grounded and that are culturally sensitive and compatible with Chinese culture is one promising strategy that may improve treatment outcomes for this understudied group. The goal of this study is to culturally adapt a cognitive-behavioral therapy manual for use with depressed Chinese American patients. This study will be among the first to develop a culturally adapted EBT for use with this ethnic group and will involve three study phases. Phase I of the study will focus on modifying and refining a CBT intervention protocol into a manualized treatment for Chinese Americans. Phase two involves a randomized controlled trial (RCT) comparing the effects of the culturally adapted CBT treatment manual with nonadapted CBT. Phase three will involve further refinement of the treatment manual, data analysis, and report writing. Patients will be recruited from an ethnic-specific mental health center that specializes in treating Asian American clientele to participate in the study. Patients will be randomly assigned to either the adapted CBT treatment or the nonadapted CBT treatment. Moreover, feedback from patients and therapists in both conditions will be used to further refine the new treatment manual, provide valuable information about salient issues in treating depressed Chinese Americans, and will provide initial estimates of treatment parameters that will be used in preparing a larger R01 proposal to further test the adapted intervention.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- depression, Chinese American

Exclusion Criteria:

- bipolar, psychotic disorder, primary substance abuse problem, severe medical conditions that induce depression

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive behavioral therapy
cognitive behavioral therapy. 12 sessions.
culturally adapted cognitive behavioral therapy
culturally adapted cognitive behavioral therapy for Chinese Americans. 12 sessions.

Locations

Country Name City State
United States Claremont McKenna College Claremont California

Sponsors (2)

Lead Sponsor Collaborator
Claremont McKenna College University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Rating Scale (Change is being assessed) most commonly used depression rating scale baseline, session 4, 8, 12, and three months follow-up No
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