Prevalence Study of Depression in Chinese Patients With Type 2 Diabetes (HK13)

Depression Clinical Trial

— DD2  

Official title:

A Multicentre Study to Investigate the Prevalence and Factors Associated With Depression in Chinese Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277432
• Other study ID #: CRE-2010-281
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: August 20, 2015
• Start date: July 2010
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The investigators aim to:

1. Estimate the prevalence of depression in a consecutive cohort of Chinese patients diagnosed with Type 2 Diabetes (T2D) living in areas of China with different socioeconomical affluence

2. Examine patients' awareness of the frequent coexistence of these 2 conditions

3. Analyze the associations between depression and T2D, in particularly the role of metabolic control, socioeconomical status and cognitive-psychological-behavioral factors

4. To document the predisposing, precipitating and perpetuating factors for depression and their interrelationships in Chinese type 2 diabetic patients

Description:

Overall objectives of this multicentre study are to document;

1. the prevalence and diagnosis rates of depression in type 2 diabetic (T2D) patients attending 7 centres in 4 major cities in China including Hong Kong (HK), Shanghai (SH), Guangzhou (GZ) and Beijing (BJ)

2. the predisposing, precipitating and perpetuating factors for depression and their interrelationships in Chinese T2D patients

This study includes two phases. In the phase I pilot study, the investigators shall confirm and compare the validity of Patient Health Questionnaire (PHQ-9) and Clinical Epidemiological Scale for Depression (CESD) in predicting depression in Chinese T2D patients using the SCID as a gold standard. Other questionaires which measure personal and external factors, diabetes associated distress and anxiety, quality of life, mental wellness, self efficacy, health-related behavior and compliance will also be used to document possible predisposing, precipitating and perpetuating factors for depression in diabetes. These results will be used to select a set of tools which are most informative in the evaluation of depression and mental wellness in T2D patients based on their predictions for health behavior, compliance and metabolic control. A random sample of 100 T2D patients will be recruited from 3 Diabetes Centres in GZ, BJ and HK who will complete a full set of questionnaires and structured clinical assessments using a web-based electronic portal. In each of the three centres, all patients found to have positive symptoms for mild to severe depression by PHQ9 or CESD (PHQ>10 and/or CES>16) and a random sample of 20 subjects with no or mild symptoms will undergo face-to-face interview by psychiatrists using the following instruments: SCID, BDI, SSI-28 (somatization), Coping (Brief Cope 28, Chinese version).

In Phase II, the investigators shall use a subset of the most informative questionaires to document the rates of depression (diagnosed and undiagnosed) and cognitive-psychological-behavioral factors in a consecutive cohort of Chinese patients with T2D and its associations with metabolic control and psychological behavioral factors. In each of the 7 participating centres in HK, SH, BJ and GZ, 500 consecutive patients will undergo comprehensive clinical assessments for risk factors, complications and medications the JADE (Joint Asia Diabetes Evaluation) e-portal, giving a total of 3500 patients.

This survey which documents the rate of depression in T2D patients using similar methodologies will provide a comprehensive data set for exploratory analysis of the multicausality and heterogeneity of clinical presentation and risk factors in Chinese populations. Once this cohort is established and subject to availability of future funding, they can be followed up prospectively to validate and discover risk factors for new onset of depression. Apart from raising awareness, these data are essential in our design of care models and interventions to tailor the unmet needs of these patients. Data from this study will also provide insights into the effects of rapid acculturation and migration on the double burden of diabetes and depression in Chinese populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3218
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes

2. Aged =25 and <75 years inclusive

3. Chinese ethnicity

Exclusion Criteria:

1. Patients with mental/physical handicap and/or difficulty in communication such as deafness, mental retardation

2. Patients with disabling diseases or reduced life expectancy such as severe heart failure, stroke, respiratory diseases, or late stages of cancer

3. Patients diagnosed with type 1 diabetes, defined as presentation with diabetic ketoacidosis or unprovoked ketosis or requirement of continuous insulin requirement within 12 months of diagnosis

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes

Intervention

Other:
• Psychiatrist Interview
Patients will receive a face-to-face interview by a trained clinician or psychiatrist using the following instruments: MINI SSI-28 (somatization)
• Depression screening - control
All study participants will undergo; a comprehensive diabetes assessment by completing a full set of questionnaires and clinical assessments, using the JADE e-portal a detailed psychological and behavioral assessments using validated questionnaires several specialist questionnaires on depression, self care and quality of life

Locations

Country	Name	City	State
China	1st Affiliated Hosp, Peking University	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Peking Union Hospital	Beijing
China	Peking University People's Hospital	Bejing
China	Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou
China	Shanghai Sixth People's Hospital	Shanghai
Hong Kong	YCK Diabetes Assessment Centre, Prince of Wales Hospital	Shatin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Asia Diabetes Foundation

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression and psychological well-being	Depression (PHQ-9, CESD); Depression Anxiety and Stress Scale (DASS-21); Diabetes Stress Scale (DSS-17)	1 year	No
Secondary	Percentage of patients who attain 2 or more of the 'ABC' targets	Percentage of patients who attain 2 or more of the following 3 targets: HbA1c <7%; BP <130/80 mmHg; LDL cholesterol <2.6 mmol/L	1 year	No
Secondary	Self care and Efficacy	Diabetes Empowerment Scale (C-DES); Summary of Diabetes Self Care Activities (SDSCA-15)	1 year	No
Secondary	Quality of life	Using EuroQol-5D (EQ-5D) tool	1 year	No

External Links

•   Works of the Asia Diabetes Foundation