DepressionNCT00854542
Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
A study testing Telepsychiatry-based Culturally Sensitive Collaborative Treatment in people with Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed Chinese Americans and by their primary care clinicians. Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT will have improved outcomes compared to patients who receive Usual Care by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Telepsychiatry-based Culturally Sensitive Collaborative Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with Chinese ethnicity, defined as people who self-identify as being Chinese based upon having either one or both parents being ethnic Chinese.
- Monolingual Chinese American immigrants, defined as people who require or prefer to be interviewed in Chinese (including Cantonese, Taiwanese, Mandarin, and Toisanese dialects).
- Men or women age 18 or older, who live in the greater Boston area.
- Individuals who are competent to consent and have completed a written consent form.
- Individuals who have a PCP.
- Patients who screen positive for MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998)
- Individuals who are willing to receive phone interviews for monitoring of symptoms and for additional support (care management) if available.
Who cannot join
- Patients with serious suicidal risk.
- Patients with unstable medical illnesses requiring imminent hospitalization or rendering patients unsuitable for clinical interview.
- Patients with comorbid severe mental disorders including:
- Organic mental disorders.
- Alcohol or substance abuse disorders active within the last year.
- Schizophrenia.
Show all 9Show fewer
- Delusional disorder.
- Psychotic disorders not elsewhere classified.
- Bipolar disorder. e. Patients with history of treatment by a psychiatrist in the past 4 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Cove Community Health Center
Boston, Massachusetts, 02111
About this study
Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed Chinese Americans and by their primary care clinicians.
Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT will have improved outcomes compared to patients who receive Usual Care by primary care physicians.
Read the detailed description
Telepsychiatry-based CSCT (T-CSCT):
Live and interactive Telepsychiatry (using videoconferencing) brings tremendous opportunities to clinical care, education, research, and administration. In the U.S. to date, telepsychiatry has been implemented in rural areas where people lack access to psychiatrists (Baer et al, 1997), in the Prison System with service users constrained from traveling (Brecht et al., 1996), in rural native American resettlement areas (Shore \& Spero, 2005), and in Alaska where residents are faced with both distance and a shortage of mental health professionals. In this proposed study, we plan to investigate the effectiveness of telepsychiatry-based CSCT (T-CSCT) to provide culturally sensitive collaborative management of MDD to monolingual Chinese Americans. For this group of patients, telepsychiatry consultation could be a necessity both in urban as well as rural primary care clinics that are not staffed with bilingual psychiatrists. T-CSCT plans to utilize the advanced telemedicine technology in major academic centers to connect the scarce resource of bilingual and bicultural mental health professionals to underserved Chinese Americans to improve their access to treatment of MDD.
T-CSCT will explore the usefulness and effectiveness of recognizing MDD subjects through consumer-initiated depression self-screening using the validated CB-PHQ-9, which will be made available in community newspapers, journals, and on the internet. To facilitate care management for Chinese Americans, a Depression Toolkit for Chinese Americans will be developed, which will include information on the nature and treatment of MDD, the CB-PHQ-9 for depression self-screening, a bilingual instrument to monitor progress of depressive symptoms, strategies for patients to negotiate with health professionals for individually tailored treatment for depression, and answers to frequently asked questions (FAQs) by Asian American immigrants on MDD and its treatment. If shown to be effective, the T-CSCT can be the prototype of a telemedicine-based Multiracial Mental Health Resource Center to provide services to other minority populations to reduce disparities in mental health treatment.
- Conditions
- Depression
- Being tested
- Telepsychiatry-based Culturally Sensitive Collaborative Treatment
- Keywords
- Telepsychiatry, Culturally Sensitive Collaborative Treatment, Chinese Americans, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telepsychiatry-based Culturally Sensitive Collaborative TreatmentBehavioural
T-CSCT: Patients in Group A will receive T-CSCT, which consists of Telepsychiatry-based Culturally Sensitive Psychiatry Assessment using the Engagement Interview Protocol (EIP) plus Care Management.
| Study group | Role | What they receive |
|---|---|---|
| TCSCT | Active comparator | Not described Receives: Behavioral: Telepsychiatry-based Culturally Sensitive Collaborative Treatment |
| Usual Care | Placebo comparator | Not described Receives: Behavioral: Telepsychiatry-based Culturally Sensitive Collaborative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: Screen, Week 9, 17, 24
Secondary outcomes (1)
Clinical Global Impressions (Severity of Depression and Global Improvement)
Measured: Screen, Week 9, 17, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Yeung, Massachusetts General Hospital
- Investigators
- Albert Yeung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854542
- Sponsor's protocol ID
- 2008P001437
- Status last verified
- Nov 2016
- First submitted
- 27 Feb 2009
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen JA, Shapero BG, Trinh NT, Chang TE, Parkin S, Alpert JE, Fava M, Yeung AS. Association Between Stigma and Depression Outcomes Among Chinese Immigrants in a Primary Care Setting. J Clin Psychiatry. 2016 Oct;77(10):e1287-e1292. doi: 10.4088/JCP.15m10225.
PubMed 27631145Yeung A, Martinson MA, Baer L, Chen J, Clain A, Williams A, Chang TE, Trinh NH, Alpert JE, Fava M. The Effectiveness of Telepsychiatry-Based Culturally Sensitive Collaborative Treatment for Depressed Chinese American Immigrants: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Aug;77(8):e996-e1002. doi: 10.4088/JCP.15m09952.
PubMed 27561153Yeung A, Hails K, Chang T, Trinh NH, Fava M. A study of the effectiveness of telepsychiatry-based culturally sensitive collaborative treatment of depressed Chinese Americans. BMC Psychiatry. 2011 Sep 26;11:154. doi: 10.1186/1471-244X-11-154.
PubMed 21943315
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telepsychiatry-based Culturally Sensitive Collaborative Treatment of Depressed Chinese Americans
- ClinicalTrials.gov ID
- NCT00854542
- Acronym / sponsor ID
- 2008P001437
- Conditions
- Depression
- Keywords
- Telepsychiatry, Culturally Sensitive Collaborative Treatment, Chinese Americans, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 3 Mar 2009 (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.
Hypothesis 1. Telepsychiatry consultations will be acceptable and well-received by depressed Chinese Americans and by their primary care clinicians.
Hypothesis 2. Depressed Chinese Americans in remote primary care clinics receiving T-CSCT will have improved outcomes compared to patients who receive Usual Care by primary care physicians.
Detailed description
Telepsychiatry-based CSCT (T-CSCT):
Live and interactive Telepsychiatry (using videoconferencing) brings tremendous opportunities to clinical care, education, research, and administration. In the U.S. to date, telepsychiatry has been implemented in rural areas where people lack access to psychiatrists (Baer et al, 1997), in the Prison System with service users constrained from traveling (Brecht et al., 1996), in rural native American resettlement areas (Shore \& Spero, 2005), and in Alaska where residents are faced with both distance and a shortage of mental health professionals. In this proposed study, we plan to investigate the effectiveness of telepsychiatry-based CSCT (T-CSCT) to provide culturally sensitive collaborative management of MDD to monolingual Chinese Americans. For this group of patients, telepsychiatry consultation could be a necessity both in urban as well as rural primary care clinics that are not staffed with bilingual psychiatrists. T-CSCT plans to utilize the advanced telemedicine technology in major academic centers to connect the scarce resource of bilingual and bicultural mental health professionals to underserved Chinese Americans to improve their access to treatment of MDD.
T-CSCT will explore the usefulness and effectiveness of recognizing MDD subjects through consumer-initiated depression self-screening using the validated CB-PHQ-9, which will be made available in community newspapers, journals, and on the internet. To facilitate care management for Chinese Americans, a Depression Toolkit for Chinese Americans will be developed, which will include information on the nature and treatment of MDD, the CB-PHQ-9 for depression self-screening, a bilingual instrument to monitor progress of depressive symptoms, strategies for patients to negotiate with health professionals for individually tailored treatment for depression, and answers to frequently asked questions (FAQs) by Asian American immigrants on MDD and its treatment. If shown to be effective, the T-CSCT can be the prototype of a telemedicine-based Multiracial Mental Health Resource Center to provide services to other minority populations to reduce disparities in mental health treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCSCT | Active comparator | Behavioral: Telepsychiatry-based Culturally Sensitive Collaborative Treatment |
| Usual Care | Placebo comparator | Behavioral: Telepsychiatry-based Culturally Sensitive Collaborative Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals with Chinese ethnicity, defined as people who self-identify as being Chinese based upon having either one or both parents being ethnic Chinese.
- Monolingual Chinese American immigrants, defined as people who require or prefer to be interviewed in Chinese (including Cantonese, Taiwanese, Mandarin, and Toisanese dialects).
- Men or women age 18 or older, who live in the greater Boston area.
- Individuals who are competent to consent and have completed a written consent form.
- Individuals who have a PCP.
Key exclusion criteria (9 listed)
- Patients with serious suicidal risk.
- Patients with unstable medical illnesses requiring imminent hospitalization or rendering patients unsuitable for clinical interview.
- Patients with comorbid severe mental disorders including:
- Organic mental disorders.
- Alcohol or substance abuse disorders active within the last year.
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 |
|---|---|---|
| Telepsychiatry-based Culturally Sensitive Collaborative TreatmentT-CSCT: Patients in Group A will receive T-CSCT, which consists of Telepsychiatry-based Culturally Sensitive Psychiatry Assessment using the Engagement Interview Protocol (EIP) plus Care Management. | Behavioural | TCSCT, Usual Care |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: Screen, Week 9, 17, 24
1 secondary outcome
Clinical Global Impressions (Severity of Depression and Global Improvement)
Time frame: Screen, Week 9, 17, 24
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 1 Dec 2016.
- Derived from this study: PubMed 27631145Chen JA, Shapero BG, Trinh NT, Chang TE, Parkin S, Alpert JE, Fava M, Yeung AS. Association Between Stigma and Depression Outcomes Among Chinese Immigrants in a Primary Care Setting. J Clin Psychiatry. 2016 Oct;77(10):e1287-e1292. doi: 10.4088/JCP.15m10225.
- Derived from this study: PubMed 27561153Yeung A, Martinson MA, Baer L, Chen J, Clain A, Williams A, Chang TE, Trinh NH, Alpert JE, Fava M. The Effectiveness of Telepsychiatry-Based Culturally Sensitive Collaborative Treatment for Depressed Chinese American Immigrants: A Randomized Controlled Trial. J Clin Psychiatry. 2016 Aug;77(8):e996-e1002. doi: 10.4088/JCP.15m09952.
- Derived from this study: PubMed 21943315Yeung A, Hails K, Chang T, Trinh NH, Fava M. A study of the effectiveness of telepsychiatry-based culturally sensitive collaborative treatment of depressed Chinese Americans. BMC Psychiatry. 2011 Sep 26;11:154. doi: 10.1186/1471-244X-11-154.
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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.
Albert Yeung, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telepsychiatry-based Culturally Sensitive Collaborative Treatment in people with Depression, run by Massachusetts General Hospital 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 7 inclusion and 9 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 1 Dec 2016. 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. Some participants in this study may receive a placebo. 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 Rating Scale for Depression (time frame: Screen, Week 9, 17, 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00854542, which also lists 3 linked publications.
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 1 Dec 2016.