NCT00854542

Brief 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 primary care physicians.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

December 1, 2016

Status Verified

November 1, 2016

Enrollment Period

5 years

First QC Date

February 27, 2009

Last Update Submit

November 30, 2016

Conditions

Depression

Keywords

TelepsychiatryCulturally Sensitive Collaborative TreatmentChinese AmericansDepression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression

    Screen, Week 9, 17, 24

Secondary Outcomes (1)

  • Clinical Global Impressions (Severity of Depression and Global Improvement)

    Screen, Week 9, 17, 24

Study Arms (2)

TCSCT

ACTIVE COMPARATOR
Behavioral: Telepsychiatry-based Culturally Sensitive Collaborative Treatment

Usual Care

PLACEBO COMPARATOR
Behavioral: Telepsychiatry-based Culturally Sensitive Collaborative Treatment

Interventions

Telepsychiatry-based Culturally Sensitive Collaborative TreatmentBEHAVIORAL

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.

TCSCTUsual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with serious suicidal risk.
  • Patients with unstable medical illnesses requiring imminent hospitalization or rendering patients unsuitable for clinical interview.
  • d. Patients with comorbid severe mental disorders including:
  • Organic mental disorders.
  • Alcohol or substance abuse disorders active within the last year.
  • Schizophrenia.
  • Delusional disorder.
  • Psychotic disorders not elsewhere classified.
  • Bipolar disorder. e. Patients with history of treatment by a psychiatrist in the past 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Cove Community Health Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

  • 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.

    PMID: 27631145DERIVED

  • Yeung 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.

    PMID: 27561153DERIVED

  • Yeung 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.

    PMID: 21943315DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Albert Yeung, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Albert Yeung, MD

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 3, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

April 1, 2015

Last Updated

December 1, 2016

Record last verified: 2016-11

Locations

US(1)