Major DepressionNCT01786746
Adapting Cognitive Behavioral Therapy (CBT) for Chinese Americans
A study testing cognitive behavioral therapy and culturally adapted cognitive behavioral therapy in people with Major Depression, run by Claremont McKenna College at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- cognitive behavioral therapy and culturally adapted cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- depression, Chinese American
Who cannot join
- bipolar, psychotic disorder, primary substance abuse problem, severe medical conditions that induce depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Claremont McKenna College
Claremont, California, 91711
About this study
Official title: Cognitive Behavioral Therapy (CBT)
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.
Read the detailed 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.
- Conditions
- Major Depression
- Being tested
- cognitive behavioral therapy, culturally adapted cognitive behavioral therapy
- Keywords
- depression, cognitive behavioral therapy, culture, Chinese Americans, psychotherapy
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral therapyBehavioural
cognitive behavioral therapy. 12 sessions.
culturally adapted cognitive behavioral therapyBehavioural
culturally adapted cognitive behavioral therapy for Chinese Americans. 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Experimental | Psychotherapy arm that consists of a randomization into 12 session manualized cognitive behavioral therapy or culturally adapted cognitive behavioral therapy for Chinese Americans. Receives: Behavioral: cognitive behavioral therapy; Behavioral: culturally adapted cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (Change is being assessed)
most commonly used depression rating scale
Measured: baseline, session 4, 8, 12, and three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJun 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claremont McKenna College
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Wei-Chin Hwang, Claremont McKenna College
- Investigators
- Wei-Chin Hwang, PhD, Principal investigator, Claremont McKenna College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786746
- Sponsor's protocol ID
- R34MH073545
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy (CBT)
- ClinicalTrials.gov ID
- NCT01786746
- Acronym / sponsor ID
- R34MH073545
- Conditions
- Major Depression
- Keywords
- depression, cognitive behavioral therapy, culture, Chinese Americans, psychotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Claremont McKenna CollegeUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Jun 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Experimental | Behavioral: cognitive behavioral therapy, Behavioral: culturally adapted cognitive behavioral therapyPsychotherapy arm that consists of a randomization into 12 session manualized cognitive behavioral therapy or culturally adapted cognitive behavioral therapy for Chinese Americans. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- depression, Chinese American
Key exclusion criteria (1 listed)
- bipolar, psychotic disorder, primary substance abuse problem, severe medical conditions that induce depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behavioral therapycognitive behavioral therapy. 12 sessions. | Behavioural | Psychotherapy |
| culturally adapted cognitive behavioral therapyculturally adapted cognitive behavioral therapy for Chinese Americans. 12 sessions. | Behavioural | Psychotherapy |
Primary outcome
Hamilton Depression Rating Scale (Change is being assessed)
Time frame: baseline, session 4, 8, 12, and three months follow-up
most commonly used depression rating scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei-Chin Hwang, PhD principal investigator
Claremont McKenna College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive behavioral therapy and culturally adapted cognitive behavioral therapy in people with Major Depression, run by Claremont McKenna College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (Change is being assessed) (time frame: baseline, session 4, 8, 12, and three months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2013.